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FDA Approves First Cancer Treatment For Any Solid Tumor With A Specific Genetic Feature – microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

Posted May 25, 2017

On May 23, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H...

Pebrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma

Posted May 18, 2017

Click here to read the corporate announcement.   On May 18, 2017, the U.S. Food and Drug Administration granted regular approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment...

Pembrolizumab (KEYTRUDA) for classical Hodgkin lymphoma

Posted May 18, 2017

On March 14, 2017, The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA), Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy. Approval was based on data from 210 adult...

FDA grants accelerated approval to Merck’s KEYTRUDA® in combination with pemetrexed and carboplatin for initial treatment of metastatic non-squamous NSCLC

Posted May 11, 2017

Read Merck’s announcement. Click here for corporate press release On May 10, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA® , Merck and Co., Inc.) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC).   Approval was based...

FDA Grants Accelerated Approval to EMD Serono’s (BAVENCIO) avelumab for Urothelial Carcinoma

Posted May 10, 2017

On May 9, 2017, the U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Approval was based on data from an open-label, single...

Novartis Receives FDA Approval for Rydapt® in Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML) and Three Types of Systemic Mastocytosis (SM)

Posted May 4, 2017

On April 28, 2017, the U.S. Food and Drug Administration approved midostaurin (RYDAPT, Novartis Pharmaceuticals Corp.) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive (FLT3+), as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. The FDA also approved...

Takeda Announces FDA Accelerated Approval of ALUNBRIGTM (brigatinib)

Posted May 4, 2017

On April 28, 2017, the U.S. Food and Drug Administration granted accelerated approval to brigatinib (ALUNBRIG tablets, Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Approval...

astrazeneca

AstraZeneca Immunotherapy Wins First Approval In Bladder Cancer

Posted May 4, 2017

Learn More at https://www.imfinzi.com/    On May 1, 2017, the U.S. Food and Drug Administration granted accelerated approval to durvalumab (IMFINZI, AstraZeneca UK Limited) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or...

bayer health

FDA Approves Regorafenib for Liver Cancer

Posted April 27, 2017

On April 27, 2017 the U.S. Food and Drug Administration expanded the indications of regorafenib (STIVARGA, Bayer HealthCare Pharmaceuticals Inc.) to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval was based on an international, multicenter, randomized, double-blind, placebo-controlled trial of 573 patients with Child-Pugh A and...

FDA Approves Cancer Immunotherapy TECENTRIQ as Initial Treatment for Certain People with Advanced Bladder Cancer

Posted April 18, 2017

The FDA approved Tecentriq (atezolizumab) as a first-line treatment for people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. The Genentech press release including Important Safety Information is linked here. This approval is important news for a number of reasons: According to the American Cancer Society, it is...

FDA removes Risk Evaluation Management Strategies (REMS) for ESAs

Posted April 13, 2017

U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy. Below is the Agency’s announcement regarding this action: Epoetin alfa and darbepoetin alfa are Erythropoiesis-Stimulating Agents (ESAs), approved for the treatment of anemia (low...

Ipsogen JAK2 RGQ PCR Kit

Posted April 13, 2017

The U.S. Food and Drug Administration has granted marketing authorization to  ipsogen JAK2 RGQ PCR Kit, manufactured by QIAGEN GmbH., to detect mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV). Diagnoses of PV are based on...

tesaro

FDA approves new drug for adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers

Posted April 6, 2017

The U.S. Food and Drug Administration approved Zejula (niraparib) for the maintenance treatment (intended to delay cancer growth) of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, whose tumors have completely or partially shrunk (complete or partial response, respectively) in response to platinum-based chemotherapy. Common side effects of Zejula include low...

astrazeneca

FDA Grants Full Approval for TAGRISSO

Posted April 4, 2017

FLASCO Diamond Corporate Member, AstraZeneca, is pleased to inform you that the US Food and Drug Administration (FDA) granted full approval for TAGRISSO® (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed...

FDA Approves EMD Serono’s Avelumab for Merkel Cell Carcinoma

Posted March 24, 2017

The U.S. Food and Drug Administration today granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. This is the first FDA-approved treatment for metastatic MCC, a rare, aggressive form of skin cancer....

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Adult and Pediatric Patients with Classical Hodgkin Lymphoma (cHL) Refractory to Treatment, or Who Have Relapsed After Three or More Prior Lines of Therapy

Posted March 16, 2017

On March 14, 2017, The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA), Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy. Approval was based on data from 210 adult...

FDA approves ribociclib in combination with an aromatase inhibitor for HR-positive, HER2-negative advanced or metastatic breast cancer

Posted March 16, 2017

On March 13, 2017, the U.S. Food and Drug Administration approved ribociclib (KISQALI®, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Approval was...

FDA Approves Lexicon Drug XERMELO™ (telotristat ethyl) 250 mg As First And Only Oral Treatment For Carcinoid Syndrome Diarrhea In Cancer Patients With Metastatic Neuroendocrine Tumors

Posted March 1, 2017

The U.S. Food and Drug Administration approved Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled. Carcinoid syndrome is a cluster of symptoms sometimes seen in people with carcinoid tumors. These tumors are rare, and often slow-growing....

FDA Expands Indication for REVLIMID® (lenalidomide) as a Maintenance Treatment for Patients with Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplant (auto-HSCT)

Posted February 23, 2017

On February 22, 2017, the U.S. Food and Drug Administration approved lenalidomide (Revlimid®, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. In 2006, lenalidomide, an orally administered thalidomide analogue, received FDA approval for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy....

Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) in Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer

Posted February 6, 2017

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved Opdivoinjection, for intravenous use for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment...

foundation medicine

Foundation Medicine Receives FDA Approval of FoundationFocus™ CDxBRCA as a Companion Diagnostic for Rubraca™ (rucaparib) for the Treatment of Women with Ovarian Cancer

Posted December 29, 2016

–FDA approval of FoundationFocus CDxBRCA marks important progress towards Foundation Medicine’s development of a comprehensive universal companion diagnostic assay across multiple tumor types to advance precision medicine in oncology–   Foundation Medicine, Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved FoundationFocus™ CDxBRCA for use as a companion diagnostic to aid in identifying women with ovarian cancer...

FDA Approves AeroForm Tissue Expander for Breast Reconstruction After Mastectomy

Posted December 28, 2016

The FDA has approved AeroForm, a balloon-like wireless tissue expander, for patients who choose to have reconstructive surgery following a mastectomy or for those with underdeveloped breasts and soft tissue deformities.   Devices like AeroForm are utilized before breast reconstruction to stretch breast tissue and muscle to create space for the implant. The FDA approved...

clovis oncology

FDA Grants Accelerated Approval To Rucaparib

Posted December 22, 2016

On December 19, 2016, the U.S. Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA™, Clovis Oncology Inc.) for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. In conjunction with the drug approval, FDA approved the FoundationFocus™ CDxBRCA test...

FDA Approves Bevacizumab for Platinum-Sensitive Ovarian Cancer

Posted December 7, 2016

FDA Approves Genentech’s Avastin® (Bevacizumab) Plus Chemotherapy for a Specific Type of Advanced Ovarian Cancer Approval based on two large Phase III studies including GOG-0213 that showed a five month overall survival difference for women with platinum-sensitive recurrent ovarian cancer on Avastin plus chemotherapy compared to chemotherapy alone In the United States, Avastin is now...

jansen

FDA Approves Daratumumab Triplets for Relapsed Myeloma

Posted November 22, 2016

On November 21, 2016, the U.S. Food and Drug Administration approved daratumumab (DARZALEX, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Daratumumab was previously  granted accelerated approval in November 2015 as monotherapy for patients...

FDA approves nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck

Posted November 10, 2016

On November 10, 2016, the U. S. Food and Drug Administration approved nivolumab (OPDIVO Injection, Bristol-Myers Squibb Company), for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy. Approval was based on data from an international, multi-center, open-label,...

FDA approves pembrolizumab for treatment of non-small cell lung cancer

Posted October 27, 2016

Pembrolizumab (KEYTRUDA)   On October 24, 2016, the U.S. Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test. This is the first FDA approval of a checkpoint inhibitor for first-line treatment...

Final Results of NAPOLI-1 Study Confirm Overall Survival and Progression-Free Survival Benefit for the ONIVYDE(R) Regimen for Patients with Metastatic Pancreatic Cancer

Posted October 20, 2016

  – ONIVYDE® in combination with fluorouracil (5-FU) and leucovorin establishes a new standard of care for patients with metastatic pancreatic cancer who have progressed on gemcitabine-based therapy – Disease control achieved in twice as many patients treated with ONIVYDE in combination with 5-FU and leucovorin (52%) compared to 5-FU and leucovorin alone (24%) CAMBRIDGE,...

FDA modifies use of erlotinib in NSCLC to include only patients whose tumors harbor EGFR mutations

Posted October 20, 2016

On October 18, 2016, the U.S. Food and Drug Administration modified the indication for erlotinib (TARCEVA, Astellas Pharm Global Development Inc.) for treatment of non-small cell lung cancer (NSCLC) to limit use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations. The labeling change applies to patients with NSCLC receiving maintenance or...

FDA Approves Cancer Immunotherapy TECENTRIQ For People With Specific Type Of Metastatic Lung Cancer

Posted October 20, 2016

On October 18, 2016, FDA approved atezolizumab (TECENTRIQ, Genentech Oncology) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving atezolizumab. Atezolizumab is a programmed...

FDA Approves Lilly’s LARTRUVO™ (olaratumab) in Combination with Doxorubicin for Soft Tissue Sarcoma

Posted October 20, 2016

— LARTRUVO, in combination with doxorubicin, is the first FDA-approved front-line therapy for soft tissue sarcoma in four decades — The approval was based on results from the positive Phase 2 JGDG trial — LARTRUVO received the FDA’s Breakthrough Therapy Designation and was approved under the Agency’s Accelerated Approval program Eli Lilly and Company (NYSE:...

ARRANON® (nelarabine) NDC NUMBER CHANGE

Posted October 13, 2016

NDC NUMBER CHANGE Former GlaxoSmithKline (fGSK) Products EFFECTIVE IMMEDIATELY, please note that the current NDC numbers are being replaced by the NEW NDC NUMBERS referenced below: Product Name: ARRANON® (nelarabine) Old NDC #0007-4401-06 New NDC # 0078-0683-06 Package Size: 6 vials x 50 mL Package Strength: 250 mg/50 mL Direct Purchasers:  Effective immediately, please use the New...

Announcing a Unique C-code for a Genentech BioOncology(R) product

Posted October 5, 2016

The following is important information regarding a unique C-code that was recently assigned to TECENTRIQ™ (atezolizumab) by the Centers for Medicare & Medicaid Services (CMS). The C-code for TECENTRIQ is C9483 (Injection, atezolizumab, 10 mg). The unique C-code goes into effect on October 1, 2016. Payers may require its use until a permanent J-code is...

astrazeneca

US FDA Approves TAGRISSO® (osimertinib) Blood-Based T790M Companion Diagnostic Test

Posted October 5, 2016

AstraZeneca announced that the US Food and Drug Administration (FDA) has approved a blood-based companion diagnostic for TAGRISSO® (osimertinib). The companion diagnostic for TAGRISSO is the only FDA-approved and clinically validated companion diagnostic test that uses either tissue or a blood sample to confirm the presence of a T790M mutation in patients with metastatic epidermal...

FDA Modifies nivolumab Dosing for Three Indications

Posted September 16, 2016

On September 13, 2016, the U.S. Food and Drug Administration modified the dosage regimen for nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. The currently approved recommended dosage regimens were modified to 240 mg intravenously (IV) every two weeks. The approval modifies the...

FDA Approves BLINCYTO® (blinatumomab) For Use In Pediatric Patients With Philadelphia Chromosome-Negative Relapsed Or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Posted September 16, 2016

Amgen  announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO®(blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval, and continued approval may be...

Update on the National Shortage of Bleomycin Sulfate for Injection

Posted September 16, 2016

  The FDA announced efforts to help mitigate the shortage of Bleomycin Sulfate for Injection. The agency will be coordinating with Amneal Bioscience to import its Bleomycin Sulfate Powder for Injection, which contains the same active ingredients as the FDA-approved Bleomycin Sulfate for Injection.   In April, the FDA posted information on its website regarding...

AMERIGEN Announces Final Approval From FDA For Generic Version of Temodar®

Posted September 16, 2016

Amerigen Pharmaceuticals Limited (“Amerigen”)  announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg). The product has been launched and is manufactured by Stason Pharmaceuticals, Inc. (“Stason”) in Irvine,...

TYKERB®(lapatinib)NDC NUMBER CHANGE

Posted September 16, 2016

TYKERB®(lapatinib)NDC NUMBER CHANGE Former GlaxoSmithKline (fGSK) Products EFFECTIVE IMMEDIATELY, please note that the current NDC numbers are being replaced by the  NEW NDC NUMBERS referenced in Table A below:   Table A: Product Name Old NDC # New NDC # Package Size Package Strength TYKERB® (lapatinib) 0173-0752-00 0078-0671-19 150 tablets 250mg   Direct Purchasers:Effective immediately,...

PEMBROLIZUMAB (KEYTRUDA) Is Now Indicated For Recurrent or Metastatic HNSCC

Posted September 16, 2016

  FDA granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Click here for Merck’s announcement   For More FDA Information Click Here   Medication Guide   Prescribing Information...

CVS Cuts Coverage of Dozens of Drugs in Exclusion Expansion

Posted September 16, 2016

CVS Health Corp. will add 35 products to its lists of excluded drugs in 2017 and no longer cover some treatments for cancer and diabetes, in an aggressive move to favor lower-priced treatments and target what the company called “hyperinflation” of some other products. The drug benefit manager will remove coverage for Novartis AG’s leukemia...

foundation medicine

Foundation Medicine Launches Blood-Based Liquid Biopsy, FoundationACT

Posted September 16, 2016

  Foundation Medicine has launched a new assay, FoundationACT (Assay for Circulating Tumor DNA), a rigorously validated and highly accurate blood-based circulating tumor DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available. By analyzing cell-free...

FDA Approved

FDA clears first quantitative nucleic acid assay for BCR-ABL

Posted September 16, 2016

Molecular Test to Guide CML Therapy OK’d FDA clears first quantitative nucleic acid assay for BCR-ABL A molecular diagnostic for measuring BCR-ABL levels in patients with chronic myeloid leukemia (CML) was cleared for marketing Friday, the FDA announced. It’s the first quantitative nucleic acid assay for this purpose to be approved in the U.S., the...

Merck is pleased to announce that EMEND for oral suspension is now available.

Posted August 11, 2016

Merck is pleased to announce that EMEND for oral suspension is now available. (Click the below image to enlarge)     EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist. EMEND for oral suspension is indicated in combination with other antiemetic agents, in patients 6 months of age and older for prevention of: acute and delayed nausea and...

Heron-therapeutics

Heron Therapeutics Announces U.S. FDA Approval of SUSTOL® (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting

Posted August 11, 2016

Heron Therapeutics Announces U.S. FDA Approval of SUSTOL® (granisetron) Extended-Release Injection for the Prevention of Chemotherapy-Induced Nausea and Vomiting SUSTOL is the first extended-release 5-HT3 receptor antagonist approved for the prevention of acute and delayed nausea and vomiting associated with both moderately emetogenic chemotherapy and anthracycline and cyclophosphamide combination chemotherapy regimens A standard of care...

FDA Approved pembrolizumab (KEYTRUDA) for Recurrent or Metastatic HNSCC

Posted August 9, 2016

On August 5, 2016, the U. S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp.) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The approval was based on demonstration of a...

Insys Therapeutics Announces FDA Approval of Syndros™

Posted July 7, 2016

Insys Therapeutics, Inc. (“Insys” or “the Company”) (INSY) today announced that the U.S. Food and Drug Administration (FDA) has approved Insys’ dronabinol oral solution, SyndrosTM, an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol (“THC”). Syndros is approved for use in treating anorexia associated with weight loss in patients...

RITUXAN MAINTENANCE THERAPY

Posted June 28, 2016

NATIONAL COMPREHENSIVE CANCER NETWORK®(NCCN®) STATUS1 NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY (NCCN GUIDELINES®) CATEGORY DESIGNATION1 Rituximab (RITUXAN®) is included in the NCCN Guidelines® with a category 1 designation for first-line maintenance therapy (one 375 mg/m2 dose every 2 months for 2 years) in follicular lymphoma patients initially presenting with high tumor burden1 Note: Category 1 designation is given...

tesaro

New Q code for VARUBI (rolapitant) effective 7/1/2016

Posted June 14, 2016

As you likely know, CMS has a National Coverage Determination policy outlining when to bill under Medicare Part B vs Part D when using oral anti-emetic therapies.  Under these policies, providers should bill under Part B only when specific criteria are met, including that the oral anti-emetics are used “as full replacement for the anti-emetic...

FDA Approved

FDA approves new diagnostic imaging agent to detect recurrent prostate cancer

Posted June 2, 2016

The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment. Prostate cancer is the second leading cause of death from cancer in U.S....

FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors

Posted June 2, 2016

The U.S. Food and Drug Administration today approved Netspot, the first kit for the preparation of gallium Ga 68 dotatate injection, a radioactive diagnostic agent for positron emission tomography (PET) imaging. This radioactive probe will help locate tumors in adult and pediatric patients with the rare condition, somatostatin receptor positive neuroendocrine tumors (NETs). NETs are...

FDA Approved

cobas EGFR Mutation Test v2

Posted June 2, 2016

On June 1, 2016, the U. S. Food and Drug Administration approved cobas EGFR Mutation Test v2 (Roche Molecular Systems, Inc.) using plasma specimens as a companion diagnostic test for the detection of exon 19 deletions or exon 21 (L858R) substitution mutations in the epidermal growth factor recptor (EGFR) gene to identify patients with metastatic...

Atezolizumab for Urothelial Carcinoma (Tecentriq, Genentech, Inc.)

Posted May 19, 2016

U. S. Food and Drug Administration gave accelerated approval to atezolizumab injection (Tecentriq, Genentech, Inc.) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.   Atezolizumab is a programmed...

Nivolumab (Opdivo, Bristol-Myers Squibb) for Hodgkin Lymphoma

Posted May 17, 2016

Click Here to Read the Corporate Press Release On May 17, 2016, the U. S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo, marketed by Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin...

FDA Approves Eisai’s LENVIMA® (lenvatinib) for the Treatment of Patients with Advanced Renal Cell Carcinoma in Combination with Everolimus Following Prior Anti-Angiogenic Therapy

Posted May 16, 2016

Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) approved LENVIMA® (lenvatinib), the company’s multiple receptor tyrosine kinase inhibitor, in combination with everolimus for the treatment of patients with advanced renal cell carcinoma (aRCC) who were previously treated with an anti-angiogenic therapy. This approval was based on the impressive results of the registration study (Study 205),...

astrazeneca

AstraZeneca Drug Wins Orphan Status in Thyroid Cancer

Posted May 12, 2016

Source: Reuters An experimental AstraZeneca drug that failed last year as a treatment for a rare cancer of the eye has been awarded special “orphan” status in the United States for a type of thyroid cancer. The British drugmaker, which is relying on cancer treatments to revive its fortunes following a wave of patent expiries,...

FDA Approved

TOLMAR wins FDA approval for ELIGARD to treat Advanced Prostate Cancer

Posted May 12, 2016

TOLMAR Pharmaceuticals has secured from FDA for a label update for ELIGARD, indicated for the palliative treatment of advanced prostate cancer. Stability studies demonstrated that, prior to mixing, ELIGARD may be stored at room temperature (59 – 86° F) for up to 8 weeks following removal from refrigeration. ELIGARD is the only LHRH (luteinizing hormone...

LabCorp Announces The Launch Of The Epi ProColon® Test For Colorectal Cancer Screening

Posted May 12, 2016

Source: Business Wire Laboratory Corporation of America® Holdings (LabCorp®)  today announced the launch of Epi proColon®, a blood-based test for colorectal cancer screening that was approved on April 13, 2016 for clinical use by the U.S. Food and Drug Administration (FDA). Epi proColon® is the first FDA-approved DNA based blood test for colorectal cancer. The...

Aetna Issues Positive Coverage Decision for NanoString’s Prosigna Breast Cancer Test

Posted May 9, 2016

NanoString Technologies announced today that health insurer Aetna has added the Prosigna breast cancer test to its Tumor Markers Clinical Policy Bulletin, opening the door for test coverage. Prosigna is an in vitro diagnostic test that uses the PAM50 gene expression signature to assess prognosis and risk of disease recurrence for patients with specific types...

pharmacyclics

U.S. FDA Expands IMBRUVICA (Ibrutinib) Label To Include Overall Survival Data In Previously Untreated CLL And New Indication For SLL Patients

Posted May 9, 2016

U.S. FDA Expands IMBRUVICA (Ibrutinib) Label To Include Overall Survival Data In Previously Untreated Chronic Lymphocytic Leukemia (CLL) And New Indication For Small Lymphocytic Lymphoma (SLL) Patients U.S. Food and Drug Administration (FDA) updated the IMBRUVICA® (ibrutinib) Prescribing Information (PI) to include new data from two Phase 3 trials supporting its expanded use in patients with...

foundation medicine

Foundation Medicine Announces Commercial Launch of Liquid Biopsy Assay, FoundationACT™

Posted May 5, 2016

Foundation Medicine, Inc. announced the launch of FoundationACT (Assay for Circulating Tumor DNA), an analytically validated and accurate blood-based circulating tumor DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available. By analyzing circulating tumor DNA isolated...

NOW APPROVED COTELLIC in combination with ZELBORAF® (vemurafenib)

Posted May 4, 2016

Genentech BioOncology® Access Solutions and Patient Partners™ Genentech BioOncology Access Solutions provides reliable, effective access and reimbursement services to assist your patients and practice. We can help address the needs of each patient’s coverage scenario. Available assistance for your eligible patients*: Patient situation Patient assistance option Insurance status of potentially eligible patients † Genentech does...

Exelixis Announces FDA Approval of CABOMETYX™ (Cabozantinib) Tablets for Patients with Advanced Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy

Posted April 28, 2016

On April 25, 2016, the U. S. Food and Drug Administration approved cabozantinib (CABOMETYX, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The approval was based on a randomized study in which patients with advanced renal cell carcinoma who had received prior anti-angiogenic therapy received...

FDA Approved

FDA Approves First Treatment For Rare Disease In Patients Who Receive Stem Cell Transplant From Blood Or Bone Marrow

Posted April 25, 2016

The U. S. Food and Drug Administration approved Defitelio (defibrotide sodium, Jazz Pharmaceuticals, Inc.) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm493278.htm

New C-Code Issued for Onivyde Injection

Posted April 25, 2016

Merrimack Pharmaceuticals has announced that the Centers for Medicare & Medicaid Services (CMS) issued a C-code forOnivyde™ (irinotecan liposome injection), effective April 1, 2016: C9474, Injection, irinotecan liposome, 1 mg. Onivyde (irinotecan liposome injection) is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas...

FDA Approved

Abbott Test Cleared by FDA as Companion Dx for CLL Drug

Posted April 25, 2016

Abbott announced today that the US Food and Drug Administration has granted premarket approved for the company’s Vysis CLL FISH Probe Kit as a companion diagnostic for AbbVie and Genentech’s newly approved chronic lymphocytic leukemia (CLL) drug Venclexta (venetoclax). Venclexta, a BCL-2 inhibitor, received FDA clearance this week for the treatment of CLL patients with...

Heron-therapeutics

FDA Finds No Deficiency with Heron Therapeutics’ Sustol NDA

Posted April 25, 2016

The US Food and Drug Administration (FDA) has indicated that there are no substantive deficiencies in Heron Therapeutics’ new drug application (NDA) for Sustol (granisetron) Injection (extended release) to treat acute and delayed chemotherapy-induced nausea and vomiting (CINV). Labeling negotiations are now underway. The FDA extended the original action date of 17 January twice to...

AbbVie & Genentech’s Venclexta Gets FDA Approval for a Rare Type of Leukemia

Posted April 14, 2016

On April 11, 2016, the U. S. Food and Drug Administration approved venetoclax (VENCLEXTA tablets, marketed by AbbVie, Inc. and Genentech USA, Inc.) for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. The approval was based on the...

pfizer

FDA Approves Pfizer’s Xalkori for Metastatic NSCLC

Posted March 17, 2016

On March 11, 2016, the U. S. Food and Drug Administration approved crizotinib capsules (Xalkori, Pfizer, Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are anaplastic lymphoma kinase (ALK)-positive. The current approval was based...

FDA Approved

FDA approves first coagulation factor-albumin fusion protein to treat patients with hemophilia B

Posted March 17, 2016

The U.S. Food and Drug Administration today approved Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX fusion protein product approved in the U.S. that is modified to last longer...

pharmacyclics

IMBRUVICA® (IBRUTINIB) APPROVED BY U.S. FDA FOR THE FIRST-LINE TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Posted March 17, 2016

APPROVAL BASED ON DATA FROM THE PHASE 3 RESONATE™-2 TRIAL SHOWING AN 84% REDUCTION IN THE RISK OF PROGRESSION OR DEATH WITH IMBRUVICA COMPARED TO CHLORAMBUCIL FIRST FDA-APPROVED CHEMOTHERAPY-FREE TREATMENT OPTION FOR FIRST-LINE CLL PATIENTS THIS IS THE 5TH TREATMENT INDICATION FOR IMBRUVICA AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the U.S. Food...

spectrum

FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection

Posted March 17, 2016

FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection EVOMELA Received FDA Approval for Two Indications: High-Dose Conditioning Treatment for Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplantation (ASCT) Palliative Treatment of Patients with MM Who Cannot Take Oral Therapy EVOMELA Admixture Solution is Stable for 4 Hours at Room Temperature in Addition...

pfizer

FDA Approved New Indication for IBRANCE

Posted March 3, 2016

On February 19, 2016, the U. S. Food and Drug Administration approved palbociclib (IBRANCE Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. In February 2015, FDA granted accelerated approval...

Monitoring and managing possible adverse drug reactions (ADRs) with COTELLIC + ZELBORAF1

Posted March 3, 2016

As a healthcare provider, you play an essential role in helping patients taking COTELLIC + ZELBORAF manage treatment. Genentech has created this Adverse Drug Reactions Guide as a quick reference on monitoring and managing possible serious or common ADRs.  This guide offers information on the signs and symptoms of certain possible ADRs experienced by patients...

astrazeneca

FDA Approves New Indication for FASLODEX® (fulvestrant)

Posted March 3, 2016

Approval expands use and offers additional option for women with HR+, HER2- metastatic breast cancer AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication expanding the use of FASLODEX® (fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone...

FDA Approves New Indication for Afinitor for Progressive, Nonfunctional GI and Lung NET

Posted March 3, 2016

On February 26, 2016, the U. S. Food and Drug Administration approved everolimus (Afinitor , Novartis) for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. Today’s approval was based on demonstration of improvement in progression-free survival (PFS) in...

FDA Approves New Indication for Merck’s EMEND for Injection

Posted February 18, 2016

FDA Approves New Indication for Merck’s EMEND for Injection Announcement Letter Press Release Prescribing Information Patient Product Information Merck  announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for single-dose EMEND® (fosaprepitant dimeglumine) for injection, Merck’s substance P/neurokinin-1 (NK1) receptor antagonist, in combination with other antiemetic medicines,...

FDA APPROVES EISAI’S HALAVEN® (ERIBULIN MESYLATE) INJECTION FOR THE TREATMENT OF PATIENTS WITH ADVANCED LIPOSARCOMA

Posted February 3, 2016

Eisai is pleased to announce that HALAVEN® (eribulin mesylate) Injection (0.5 mg per mL) is now approved by the US Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.1 HALAVEN has been approved for the treatment of third-line metastatic breast cancer since...

FDA Approves First Drug to Show Survival Benefit in Liposarcoma

Posted January 28, 2016

The U.S. Food and Drug Administration today approved Eisai’s Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who received prior chemotherapy that contained an anthracycline drug. “Halaven is...

Dako, an Agilent Technologies Company, Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma

Posted January 28, 2016

Dako, an Agilent Technologies Company, Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the intended use of Dako PD-L1 IHC 28-8 pharmDx to include patients...

Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status

Posted January 28, 2016

Opdivo + Yervoy Regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, based on accelerated approval1 Demonstrated significantly superior progression-free survival vs. Yervoy alone in CheckMate -067 with the first and only FDA-approved combination of immune checkpoint inhibitors1,2 FDA also expands use of Opdivo as single-agent to include previously untreated BRAF mutation-positive advanced melanoma...

abbvie logo

AbbVie, Roche’s venetoclax awarded priority review by FDA for chronic lymphocytic leukemia

Posted January 22, 2016

AbbVie and Roche’s investigational BCL-2 inhibitor venetoclax was granted priority review by the FDA for the treatment of chronic lymphocytic leukaemia (CLL) in patients, including those with p17 deletion, who received at least one prior therapy, Roche announced Tuesday. Roche chief medical officer Sandra Horning said “we look forward to working with AbbVie and health...

Ofatumumab (Arzerra Injection)

Posted January 22, 2016

On January 19, 2016, the U.S. Food and Drug Administration approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients...

FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma

Posted January 22, 2016

Originally published on CNN, here. Pivotal Head-To-Head ENDEAVOR Study Shows Kyprolis and Dexamethasone Doubled Progression-Free Survival Versus Velcade® (Bortezomib) and Dexamethasone Kyprolis Label Expansion Represents Critical Advancement for Patients With Relapsed or Refractory Multiple Myeloma, Offering New Option For Backbone Therapy Approval Expands Kyprolis Indication and Converts Monotherapy Indication to Full Approval. THOUSAND OAKS, Calif., Jan. 21,...

FDA Expands Label For Pembrolizumab (Keytruda® Injection)

Posted January 8, 2016

FDA Expands Label For Pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp) Corporate Press Release Prescribing Information Medication Guide On December 18, 2015, the U. S. Food and Drug Administration (FDA) expanded the label to include the approval of pembrolizumab (Keytruda® Injection, Merck Sharp & Dohme Corp.) for the treatment of patients with unresectable or...

J Code for KEYTRUDA® (pembrolizumab) Available

Posted January 8, 2016

 J Code for KEYTRUDA® (pembrolizumab) Available KEYTRUDA has been assigned a permanent HCPCS* code, effective January 1, 2016.1 HCPCS CODE DESCRIPTOR J9271 Injection, pembrolizumab, 1 mg   For dates of service prior to January 1, 2016, use the appropriate unspecified HCPCS code to bill for KEYTRUDA.  If you have questions about KEYTRUDA, please contact your...

FDA Approves First Emergency Treatment for Overdose of Certain Types of Chemotherapy

Posted December 17, 2015

The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments. “Treating cancer requires not only selecting which drug may...

FDA Approves New Oral Therapy to Treat ALK-Positive Lung Cancer (Genentech)

Posted December 17, 2015

Click here to read corporate press release The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib). Lung cancer is the leading cause of cancer death...

FDA Approves Bridion to Reverse Effects of Neuromuscular Blocking Drugs Used During Surgery (Merck)

Posted December 17, 2015

The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults. Rocuronium bromide and vecuronium bromide are neuromuscular blocking drugs that cause temporary paralysis by interfering with the transmission of nerve...

teva oncology

Teva Pharmaceuticals and Eagle Pharmaceuticals Announce FDA Approval of BENDEKA™ (bendamustine hydrochloride) Injection

Posted December 11, 2015

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) today announce that the U.S. Food and Drug Administration (FDA) has approved BENDEKA™, (bendamustine hydrochloride) injection, a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine. BENDEKA is approved for the treatment of patients with chronic lymphocytic leukemia (CLL) and for the treatment...

FDA Approves First Recombinant von Willebrand Factor to Treat Bleeding Episodes

Posted December 10, 2015

The U.S. Food and Drug Administration  approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD). Vonvendi is the first FDA-approved recombinant von Willebrand factor, and is approved for the on-demand (as needed) treatment and control of bleeding episodes in adults diagnosed with...

FDA Allows Marketing of Cooling Cap to Reduce Hair Loss During Chemotherapy

Posted December 10, 2015

U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy. Hair loss is a common side effect of certain types of chemotherapy, commonly associated with the treatment of breast cancer. Hair may fall out entirely, gradually, in...

New HCPCS Code for CYRAMZA®

Posted December 4, 2015

Announcing the assignment of a product-specific Healthcare Common Procedure Coding System (HCPCS) code for CYRAMZA® (ramucirumab) for injection.          The new code, J9308, is defined as Injection, ramucirumab, 5 mg. This code is effective January 1, 2016. Trade Name HCPCS Code1 Strength NDC* CYRAMZA J9308 Injection, ramucirumab, 5 mg 100 mg/10 mL (10 mg/mL)   500...

FDA Approves Empliciti, a New Immune-Stimulating Therapy to Treat Multiple Myeloma

Posted December 2, 2015

Click here to read corporate press release  U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white...

Bristol-Myers Squibb’s Empliciti Gains FDA Clearance for Multiple Myeloma

Posted December 2, 2015

Click here for corporate release   The U.S. Food and Drug Administration granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications. Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white...

FDA approves Lilly’s Portrazza to treat advanced squamous non-small cell lung cancer

Posted November 24, 2015

FDA approves Lilly’s Portrazza to treat advanced squamous non-small cell lung cancer The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. Lung...

FDA approves Bristol Myers- Squibb’s Opdivo to treat Advanced Form of Kidney Cancer

Posted November 23, 2015

On November 23, 2015, the U. S. Food and Drug Administration approved nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The approval was based on a randomized study in which patients with advanced renal cell cancer who had received prior anti-angiogenic...

FDA approves Takeda’s Ninlaro for Multiple Myeloma

Posted November 23, 2015

On November 20, 2015, the U.S. Food and Drug Administration approved ixazomib (NINLARO, Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.  Ixazomib is the first approved oral proteasome inhibitor....

Novartis receives FDA regular approval for Tafinlar® + Mekinist® to treat aggressive form of melanoma based on long-term survival data

Posted November 23, 2015

Novartis receives FDA regular approval for Tafinlar® + Mekinist® to treat aggressive form of melanoma based on long-term survival data   The U. S. Food and Drug Administration granted accelerated approval to trametinib  and dabrafenib  for use in combination in the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K...

astrazeneca

AstraZeneca’s Tagrisso approved by FDA for advanced NSCLC

Posted November 19, 2015

On November 13, 2015, the U. S. Food and Drug Administration granted accelerated approval to osimertinib (TAGRISSO) once daily tablets, AstraZeneca Pharmaceuticals LP, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine...

jansen

FDA Approves Darzalex For Patients With Previously Treated Multiple Myeloma

Posted November 19, 2015

On November 16, 2015, the U.S. Food and Drug Administration granted accelerated approval to daratumumab injection (DARZALEX, Janssen Biotech, Inc.), administered as a single agent for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are...

gilead

FDA Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Posted November 12, 2015

FDA Approves Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection The U.S. Food and Drug Administration approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of...

FDA Approves Genentech’s Cotellic™ (Cobimetinib) in Combination With Zelboraf® (Vemurafenib) in Advanced Melanoma

Posted November 12, 2015

FDA Approves Genentech’s Cotellic™ (Cobimetinib) in Combination With Zelboraf® (Vemurafenib) in Advanced Melanoma Click here to read corporate press release The U.S. Food and Drug Administration approved Cotellic (cobimetinib) to be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery,...

FDA Approves IMLYGIC™ (Talimogene Laherparepvec) As First Oncolytic Viral Therapy In The US

Posted October 28, 2015

The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes. “Melanoma is a serious disease that can advance and spread to other parts of the body, where it becomes difficult to treat,” said Karen Midthun, M.D.,...

jansen

FDA Approval for Yondelis (Janssen) for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma

Posted October 28, 2015

Yondelis (trabectedin) Janssen The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline. According to...

FDA approves new treatment for advanced pancreatic cancer

Posted October 22, 2015

The U.S. Food and Drug Administration today approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. According to the National Cancer Institute, there will be 48,960 new cases of pancreatic cancer diagnosed in the U.S. in 2015,...

rosetta genomics

Rosetta Genomics Launches BRAF Mutation Assay

Posted October 14, 2015

Rosetta Genomics Ltd. a leading developer and provider of microRNA-based and other molecular diagnostics, announces the launch of a molecular test for BRAF mutation analysis to help personalize therapy for melanoma and colon cancer patients. This newest assay will complement its broad offerings so that oncologists can optimize treatment decisions for their cancer patients. Rosetta...

FDA Expands Approved Use Of Opdivo In Advanced Lung Cancer (Bristol Myers Squibb)

Posted October 9, 2015

On October 9, 2015, the FDA approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy. “The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy....

KEYTRUDA NOW APPROVED FOR METASTATIC SQUAMOUS AND NONSQUAMOUS NSCLC (Merck)

Posted October 9, 2015

KEYTRUDA is indicated for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA. This...

FDA Approved

FDA Approves Expanded Indication For Medical Device To Treat A Form Of Brain Cancer

Posted October 9, 2015

FDA approved an expanded indication for the Optune device to treat patients with newly-diagnosed glioblastoma multiforme (GBM), an aggressive form of brain cancer. It is given along with the chemotherapy drug temozolomide (TMZ) following standard treatments that include surgery, chemotherapy, and radiation therapy.  [su_button url=”http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUxMDA3LjQ5OTcwNzExJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MTAwNy40OTk3MDcxMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MjAxMTM4JmVtYWlsaWQ9RG9yb3RoeS5HcmVlbkBmbGFzY28ub3JnJnVzZXJpZD1Eb3JvdGh5LkdyZWVuQGZsYXNjby5vcmcmZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&107&&&http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465744.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery” target=”blank” style=”flat” background=”#ff002d” color=”#fafafa” size=”5″ center=”yes” icon=”icon: hand-o-right” icon_color=”#ffffff” text_shadow=”0px...

Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma

Posted October 1, 2015

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Read Corporate Press Release FDA Information: U. S. Food and Drug Administration granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in...

Merck and Pfizer Announce FDA Orphan Drug Designation for Investigational Immunotherapy Avelumab in Merkel Cell Carcinoma

Posted October 1, 2015

(BUSINESS WIRE)–Merck and Pfizer announced that the US Food and Drug Administration (FDA) has granted orphan drug designation for the investigational cancer immunotherapy avelumab* for the treatment of Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.1,2 Each year, there are approximately 1,500 new cases of MCC diagnosed in the US.3 “We...

Moffitt Cancer Center and Bristol-Myers Squibb Enter Into a Collaboration Agreement as Part of U.S. Immuno-Oncology Rare Population Malignancy Program

Posted September 30, 2015

Moffitt Cancer Center and Bristol-Myers Squibb   Enter Into a Collaboration Agreement as Part of U.S. Immuno-Oncology Rare Population Malignancy Program   NEW YORK & TAMPA, Fla., Sep 25, 2015 (BUSINESS WIRE) — Bristol-Myers Squibb Company  and Moffitt Cancer Center today announced that they have entered into a collaboration agreement as part of Bristol-Myers Squibb’s Immuno-Oncology...

taiho oncology

U.S. Food and Drug Administration approved LONSURF® (trifluridine and tipiracil) tablets

Posted September 30, 2015

On September 22, 2015, the U.S. Food and Drug Administration approved LONSURF® (trifluridine and tipiracil) tablets. LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF...

Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial

Posted September 24, 2015

Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial   The Lancet Oncology has recently published the overall survival (OS) data from a head-to-head Phase III clinical trial. The study evaluated a lung cancer treatment as a potential option for patients with...

taiho oncology

FDA Approves New Oral Medication to Treat Patients with Advanced Colorectal Cancer

Posted September 23, 2015

FDA Approves New Oral Medication to Treat Patients with Advanced Colorectal Cancer The U.S. Food and Drug Administration today approved Taiho Oncology’s Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies. “The past decade has brought a new...

ADCETRIS® (brentuximab vedotin) NEW INDICATION

Posted September 15, 2015

ADCETRIS® (brentuximab vedotin)  NEW INDICATION   Dear Healthcare Professional: Seattle Genetics is pleased to announce FDA approval for use of ADCETRIS® (brentuximab vedotin) as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation treatment for patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression. The FDA decision was based on the positive results...

tesaro

FDA Approves Varubi (rolapitant) Treatment for Nausea and Vomiting from Chemotherapy

Posted September 2, 2015

FDA Approves Varubi (rolapitant)  Treatment for Nausea and Vomiting from Chemotherapy The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents) that prevent nausea and vomiting associated with initial and repeat courses of vomit-inducing (emetogenic...

FDA approves Promacta (eltrombopag) to Treat Low Blood Platelet Count in Pediatric Patients

Posted August 24, 2015

FDA approves Promacta (eltrombopag) to Treat Low Blood Platelet Count in Pediatric Patients The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in...

Seattle Genetics Announces FDA Regular Approval of ADCETRIS® (Brentuximab Vedotin) for Classical Hodgkin Lymphoma Patients at High Risk of Relapse or Progression as Post-Autologous Hematopoietic Stem Cell Transplantation Consolidation

Posted August 18, 2015

[su_list icon=”icon: check” icon_color=”#1243fe”] FDA Approval Based on the Phase 3 AETHERA Clinical Trial Results- AETHERA Trial Also Converts Prior Accelerated Approval to Regular Approval in Treatment of Classical Hodgkin Lymphoma Patients who Fail Autologous Hematopoietic Transplantation or who Fail at Least Two Prior Multi-Agent Chemotherapy Regimens and are Not Autologous Hematopoietic Transplantation Candidates Label...

myriad genetics

Myriad’s myPlan® Lung Cancer

Posted August 6, 2015

 Myriad’s myPlan® Lung Cancer Myriad’s myPlan® Lung Cancer is a new RNA 46-gene expression signature based on cell cycle progression (CCP) genes —the genes that regulate cell division. myPlan Lung Cancer measures the expression levels of specific genes in combination with pathological stage to predict the 5-year risk of lung cancer death in patients with...

AKYNZEO® (netupitant/palonosetron) – FLASCO News Flash

Posted August 5, 2015

AKYNZEO® (netupitant/palonosetron) Florida Society of Clinical Oncology (FLASCO) News Flash In 2014, Eisai launched AKYNZEO (netupitant/palonosetron), a dual-action, single-dose oral antiemetic for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed combination of...

Sonidegib (Odomzo Capsules) Approved by FDA

Posted July 27, 2015

Sonidegib (Odomzo Capsules) Approved by FDA (Novartis Pharmaceuticals Corporation) FDA approved sonidegib (Odomzo Capsules, Novartis Pharmaceuticals Corporation) for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. July 24, 2015. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm455865.htm

Carfilzomib (Kyprolis) Approved by FDA

Posted July 27, 2015

Carfilzomib (Kyprolis) Approved by FDA (Onyx Pharmaceuticals, Inc., an Amgen Subsidiary) On July 24, 2015, the U.S. Food and Drug Administration approved a new indication for Kyprolis® (carfilzomib) for injection.1   KYPROLIS can now be used in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to...

Afatinib versus Erlotinib as Second-line Treatment Phase III Clinical Trial Update

Posted July 23, 2015

Afatinib versus Erlotinib as Second-line Treatment Phase III Clinical Trial Update Boehringer Ingelheim Pharmaceuticals, Inc. would like to share the overall survival (OS) data from a head-to-head Phase III clinical trial that was recently published in The Lancet Oncology. The study evaluated the company’s lung cancer treatment as a potential option for patients with advanced...

Genentech’s Investigational Immunotherapy Atezolizumab Study Update

Posted July 22, 2015

In a Pivotal Study, Genentech’s Investigational Immunotherapy Atezolizumab Shrank Tumors in People With a Specific Type of Bladder Cancer Results showed that high levels of PD-L1 expression were associated with greater responses to atezolizumab Genentech will discuss results with the U.S. Food and Drug Administration (FDA) as part of atezolizumab’s Breakthrough Therapy Designation in bladder...

astrazeneca

FDA Approved AstraZeneca’s Gefitinib (Iressa)

Posted July 13, 2015

AstraZeneca recently received approval from the Food and Drug Administration for IRESSA® (gefitinib) as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. IRESSA is approved in 91 countries...

POMALYST (POMALIDOMIDE) LABEL UPDATE NOW AVAILABLE

Posted July 9, 2015

POMALYST (POMALIDOMIDE) LABEL UPDATE NOW AVAILABLE Celgene Corporation releases new phase 3 clinical trail information for Pomalyst. POMALYST (pomalidomide) + low-dose dexamethasone(dex) delivered significantly longer progression-free survival (PFS) vs high-dose dex in a phase 3 clinical trial. Pomalyst is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received...

AMGEN DISTRIBUTES IMPORTANT SAFETY UPDATES ON PROLIA®

Posted June 1, 2015

AMGEN DISTRIBUTES IMPORTANT SAFETY UPDATES ON PROLIA® The FDA has required Amgen to distribute a safety update on Prolia® (denosumab) to professional societies as part of its REMS (Risk Evaluation and Mitigation Strategy) program. Prolia® is a RANK ligand (RANKL) inhibitor used to treat osteoporosis in postmenopausal women who have high risk of bone fracture....

biodesix

NEW TEST: GENESTRAT (BIODESIX)

Posted May 21, 2015

NEW TEST: GENESTRAT (BIODESIX) Biodesix is pleased to announce the launch of GeneStrat, a liquid biopsy mutation test for genotyping tumors of NSCLC patients, is an exciting milestone for Biodesix. The combined diagnostic power of GeneStrat and VeriStrat will continue to help assist physicians in treating their patients by offering more information in a timely...

HCPCS C-CODE FOR BLINCYTO™

Posted May 18, 2015

HCPCS C-CODE FOR BLINCYTO™ Onyx Pharmaceuticals, an Amgen subsidiary, announced the assignment of HCPCS C-code for BLINCYTO™ (blinatumomab) for Injection for intravenous use1. The Centers for Medicare and Medicaid Services (CMS) assigned a unique C-code for BLINCYTO which became effective on April 1, 2015. HCPCS Code BLINCYTO Long Descriptor Strength Effective Date C9449 Injection, blinatumomab,...

GAZYVA® – NCCN GUIDELINES® CATEGORY 1 DESIGNATION

Posted May 17, 2015

GAZYVA® – NCCN GUIDELINES® CATEGORY 1 DESIGNATION Obinutuzumab (GAZYVA®) + chlorambucil is included in the NCCN Guidelines® with a category 1 designation for first-line therapy in the following CLL patients without del(17p)*: – Age ≥70 years – Younger patients (age <70 years) with significant comorbidities – Frail patients with significant comorbidities   Note: Category 1...

FDA Approved

ROCHE RECEIVES FDA APPROVAL FOR COBAS® KRAS MUTATION TEST

Posted May 16, 2015

ROCHE RECEIVES FDA APPROVAL FOR COBAS® KRAS MUTATION TEST Roche announced that the U.S. Food and Drug Administration (FDA) has approved the cobas KRAS Mutation Test for diagnostic use. The real-time polymerase chain reaction (PCR) test is designed to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer and aid clinicians in...

teva oncology

FLUOROURACIL INJECTION USP (ADRUCIL) 5 G/100 ML (50 MG/ML)

Posted May 15, 2015

FLUOROURACIL INJECTION USP (ADRUCIL) 5 G/100 ML (50 MG/ML) Teva Parenteral Medicines has issued a voluntary recall of eight lots of fluorouracil injection USP (Adrucil) 5 g/100 mL (50 mg/mL). The reason cited is the potential presence of particulate matter, namely, aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals. Individual 5...

OPDIVO NCCN GUIDELINES UPDATE

Posted May 15, 2015

OPDIVO NCCN GUIDELINES UPDATE Five days after the approval of OPDIVO for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, the National Comprehensive Cancer Network® (NCCN®) and their expert panel have made an interim update to the NCCN Guidelines® to include nivolumab (OPDIVO) as...

CMS Issued Guidance on Biosimilars

Posted May 3, 2015

  CMS Issued Guidance on Biosimilars Please review CMS Coverage of Biosimilars for more information. See new codes below: HCPCS Code Short Description Long Description Action Coverage Pricing Effective Date Q5101 Inj filgrastim g-csf biosim Injection, Filgrastim (G-CSF), Biosimilar, 1 microgram Add D 51 7/1/2015 Q9976 Inj Ferric Pyrophosphate Cit Injection, Ferric Pyrophosphate Citrate Solution,...

Ramucirumab mCRC Approved by FDA

Posted April 24, 2015

Ramucirumab mCRC On April 24, 2015, the U. S. Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) for use in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen.  Ramucirumab is a recombinant human monoclonal...

biodesix

VeriStrat®

Posted March 26, 2015

VeriStrat®   Lung Cancer Journal: VeriStrat Proteomic Test Improves Overall Survival and Decreases Medical Costs for Patients with Advanced NSCLC BOULDER, Colo.—March 24, 2015— Biodesix, Inc. today announced the publication in the journal Lung Cancer of a pivotal paper demonstrating the economic implications to the US healthcare system of using VeriStrat® in guiding treatment of...

FDA Approved

Dinutuximab

Posted March 16, 2015

FDA Approved Dinutuximab On March 10, 2015, the U. S. Food and Drug Administration approved dinutuximab (Unituxin, United Therapeutics Corporation), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Dinutuximab...

FDA Approves New Antifungal Drug Cresemba

Posted March 16, 2015

FDA Approves New Antifungal Drug Cresemba The FDA has approved Cresemba (isavuconazonium sulfate), a new antifungal drug product used to treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections. Cresemba is marketed by Astellas Pharma US, Inc., based in Northbrook, Illinois. Aspergillosis is a fungal infection caused by Aspergillus species, and mucormycosis...

sandoz

Zarxio (filgrastim-sndz)

Posted March 16, 2015

Zarxio (filgrastim-sndz) The FDA approved filgrastim-sndz (ZARXIO Injection, Sandoz Inc.), as a biosimilar to US-licensed Neupogen for the five indications for which US-licensed Neupogen is approved. The formulation of ZARXIO differs from that of US-licensed Neupogen in one inactive component. Sandoz, a subsidiary of Novartis, is the first company to get approval for a biosimilar,...

Opdivo (nivolumab)

Posted March 10, 2015

Opdivo (nivolumab) The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new diagnoses and...

ERWINAZE® (asparaginase Erwinia chrysanthemi)

Posted March 10, 2015

ERWINAZE® (asparaginase Erwinia chrysanthemi) ERWINAZE® (asparaginase Erwinia chrysanthemi) is now FDA-approved to be administered intravenously (IV) in addition to the originally approved intramuscular (IM) route of administration. ERWINAZE for intramuscular injection (IM) or intravenous infusion (IV), 10,000 International Units/vial is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with...

Panobinostat (FARYDAK)

Posted March 10, 2015

Panobinostat (FARYDAK)    Full prescribing information is available at:  http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205353s000lbl.pdf   FARYDAK® (panobinostat) capsules On February 23, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval to panobinostat (FARYDAK capsules, Novartis Pharmaceuticals) in combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior...

Revlimid

Posted March 10, 2015

Revlimid The U.S. Food and Drug Administration has expanded the authorized use of Celgene Corp’s cancer drug Revlimid to include newly diagnosed patients with multiple myeloma. Previously the drug was only approved for patients who had received at least one previous therapy. Physicians in the United States have long been prescribing Revlimid for new patients...

Lenvima (lenvatinib)

Posted March 10, 2015

Lenvima (lenvatinib) The U.S. Food and Drug Administration granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). Please see full Prescribing Information.

FDA Approves Palbociclib for Metastatic Breast Cancer

Posted March 10, 2015

FDA Approves Palbociclib for Metastatic Breast Cancer The U. S. Food and Drug Administration granted accelerated approval to palbociclib (IBRANCE®, Pfizer, Inc.) for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast for their metastatic disease. Read more

Provenge

Posted March 10, 2015

Provenge NCCN recently updated their Prostate Cancer treatment guidelines based on guidance from a panel of academic Oncologists and Urologists and patient advocacy leaders from around the country. The updated NCCN guidelines elevate PROVENGE to a more prominent position, recommending its use as the first treatment with an overall survival advantage for men with asymptomatic...

Trastuzumab Emtansine (T-DM1)*

Posted March 10, 2015

Trastuzumab Emtansine (T-DM1)* ASCO® Clinical Oncology Practice Guidelines recommend trastuzumab emtansine (T-DM1)* as second-line therapy for advanced HER2+ breast cancer1,2.   For complete information, please click here.  

KEYTRUDA Will Now Be Supplied as a 100 mg/4 mL (25 mg/mL) Solution in a Single-Use Vial

Posted March 10, 2015

KEYTRUDA Will Now Be Supplied as a 100 mg/4 mL (25 mg/mL) Solution in a Single-Use Vial Merck is pleased to announce the availability of a liquid formulation of KEYTRUDA. Merck expects to make this product available on or after February 16, 2015. Check with your authorized distributor for details. This 100-mg liquid vial will...

FDA Approved

IMBRUVICA® (ibrutinib)

Posted March 10, 2015

IMBRUVICA® (ibrutinib)   Pharmacyclics, Inc. and Janssen Biotech, Inc., are pleased to announce that, as of January 29, 2015, IMBRUVICA® (ibrutinib) has been granted regular approval by the FDA for use in patients with Waldenström’s Macroglobulinemia (WM). For updated information, please see accompanying Full Prescribing Information

FDA Approves Lanreotide For Treatment of GEP-NETs

Posted March 10, 2015

FDA Approves Lanreotide For Treatment of GEP-NETs The U. S. Food and Drug Administration approved lanreotide (Somatuline Depot Injection, Ipsen Pharma) for the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival. Lanreotide was previously approved for the long-term treatment of acromegalic patients who...

FDA Approves BLINCYTOTM (blinatumomab)

Posted March 10, 2015

FDA Approves BLINCYTOTM (blinatumomab) the U.S. Food and Drug Administration approved BLINCYTOTM (blinatumomab) for injection, for intravenous use.   Trade Name NDC* Pack Size WAC BLINCYTOTM 55513-0160-01 35 mcg lyophilized powder, single use vial IVSS (IV Solution Stabilizer) 10 mL single use vial $ 3178.57 *Note that the product’s NDC code has been “zero-filled” to...

FDA Approved

FDA Approves Companion Diagnostic for the Detection of BRCA1/2 Mutations in Ovarian Cancer (

Posted March 10, 2015

  FDA Approves Companion Diagnostic for the Detection of BRCA1/2 Mutations in Ovarian Cancer The FDA approval of olaparib occurred concurrently with that of a companion diagnostic, BRACAnalysis CDx. This genetic test is designed to detect the presence of mutations in the BRCA genes in blood samples from patients with ovarian cancer. To read more...

FDA Approved

FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer

Posted March 10, 2015

FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer The U.S. Food and Drug Administration (FDA) today granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three or more prior lines...

FDA Approves Gazyva® (Obinutuzumab)

Posted March 10, 2015

FDA Approves Gazyva® (Obinutuzumab) Supplemental Biologics License Application with New Data in Previously Untreated Chronic Lymphocytic Leukemia Genentech, a member of the Roche Group, announced that the FDA approved a supplemental biologics license application (sBLA) for Gazyva in combination with chlorambucil chemotherapy in people with previously untreated chronic lymphocytic leukemia (CLL). read corporate press release » 

Keytruda Code Update

Posted March 10, 2015

Keytruda Code Update Keytruda (Merck) has been assigned a Level II HCPCS C code, effective 1/1/2015. This code applies to Medicare hospital outpatient claims for dates of service on or after 1/1/2015. HCPCS Code : C9027 For more information click here.

FDA Approves Opdivo for Advanced Melanoma

Posted March 10, 2015

FDA Approves Opdivo for Advanced Melanoma The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs. Read press release  Click to read Opdivo Announcement For more information Opdivo  

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