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LATEST DRUG UPDATES:

 

U.S. Food and Drug Administration Approves Opdivo® (nivolumab) + Yervoy® (ipilimumab) Combination as First-Line Treatment for Patients with Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma

 The Opdivo + low-dose Yervoy combination is the first and only treatment to show significantly superior overall survival versus sunitinib in intermediate- and poor-risk advanced renal cell carcinoma, including a survival benefit regardless of PD-L1 expression 1,2 Treatment with Opdivo + Yervoy delivered higher objective response rates, including more complete responses, than sunitinib 1,2 In the CheckMate -214 trial, which used dosing optimized for advanced renal...

FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

On April 16, 2018, the Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. The approvals were based on CheckMate 214 (NCT02231749), a randomized open-label trial. Patients with previously untreated advanced RCC...

FDA approves everolimus for tuberous sclerosis complex-associated partial-onset seizures

On April 10, 2018, the Food and Drug Administration approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Everolimus is also approved for two other manifestations of TSC: TSC-associated subependymal giant cell...

clovis oncology

FDA approves Clovis Oncology’s rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer

On April 6, 2018, the Food and Drug Administration approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Approval was based on ARIEL3 (NCT01968213), a randomized, double-blind,...

FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia

On March 29, 2018, the Food and Drug Administration granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. Approval was based on the open...

Nilotinib Approved to Treat Pediatric Patients with Leukemia

The FDA approved an expanded indication for nilotinib (Tasigna) as a first- and second-line treatment for pediatric patients 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP), according to a press release. Nilotinib is currently indicated to treat both adults and pediatric patients with newly-diagnosed Ph+ CML-CP. It is...

bayer health

NCCN Recommends Regorafenib Dose Escalation in Metastatic CRC

The NCCN guidelines were updated. CRC now includes the new dose escalation for Stivarga as a result of the ReDos study.  Read more at OncLive.com here http://www.onclive.com/web-exclusives/nccn-recommends-regorafenib-dose-escalation-in-metastatic-crc.

FDA expands approval of Adcetris for first-line treatment of Stage III or IV classical Hodgkin lymphoma in combination with chemotherapy

The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. “Today’s approval represents an improvement in the initial treatment regimens of advanced Hodgkin lymphoma that were introduced into clinical practice more than 40 years ago,”...

FDA Approves sBLA Updating Nivolumab Dosing Schedule Across Indications

On March 6, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the nivolumab (Opdivo) dosing schedule to include 480 mg infused every 4 weeks for a majority of approved indications. This approval will provide health-care professionals the flexibility to customize patient care with the option of using the...

Eli Lilly and Company

FDA Approval of New Indication for Verzenio™

February 26, 2018 – The US Food and Drug Administration (FDA) approved a new indication for Verzenio™ (abemaciclib 50, 100, 150, 200 mg tablets). See below for the Indication and Important Safety Information and click to access the full Prescribing Information for Verzenio.    Dosing Regimen Tablet Strength Quantity NDC* Days of Therapy per Pack Verzenio 7-Day Dose...

New Treatment Options for Oncology Indications

In 2017, the brisk pace of drug approvals from the US Food and Drug Administration allowed an influx of new treatment options for oncology indications. These included novel breakthrough treatments for solid tumors and hematologic malignancies, new and expanded indications for existing approved therapies, and the addition of new agents in drug classes with already...

FDA approves Lilly’s abemaciclib as initial therapy for HR-positive, HER2-negative metastatic breast cancer

On February 26, 2018, the Food and Drug Administration approved abemaciclib (VERZENIO™, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Approval was based on MONARCH 3, a randomized (2:1), double-blinded,...

astrazeneca

FDA expands approval of AstraZeneca’s Imfinzi to reduce the risk of non-small cell lung cancer progressing

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). “This is the first treatment approved for stage III...

The U.S. Food and Drug Administration approved Janssen’s Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).

The U.S. Food and Drug Administration approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). This is the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer. “The FDA evaluates a variety of methods that measure a drug’s...

FDA approves new treatment for certain digestive tract cancers

The U.S. Food and Drug Administration  approved Lutathera (lutetium Lu 177 dotatate) for the treatment of a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs. Lutathera is indicated for adult...

FDA Warns About Anaphylaxis, Anaphylactic Shock With Use Of Rolapitant In Patients With Cancer.

A warning about anaphylaxis, anaphylactic shock, and other hypersensitivity reactions occurring with the use of rolapitant (Varubi, Tesaro Inc) in patients with cancer has been highlighted by the US Food and Drug Administration in a MedWatch bulletin. Rolapitant is a substance/ neurokinin receptor antagonist indicated for the prevention of delayed nausea and vomiting associated with cancer...

FDA Approves Addition Of Overall Survival Data To KYPROLIS® (carfilzomib) Label

Amgen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS® (carfilzomib). Data added to the label demonstrated that KYPROLIS and dexamethasone (Kd) reduced the risk of death by...

teva oncology

Teva Announces U.S. FDA Approval of TRISENOX® (arsenic trioxide) Injection for First Line Treatment of Acute Promyelocytic Leukemia

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the use of TRISENOX® (arsenic trioxide) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. The approval was based on...

FDA broadens afatinib indication to previously untreated, metastatic NSCLC with other non-resistant EGFR mutations

On January 12, 2018, the Food and Drug Administration granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. Approval was based on demonstration...

astrazeneca

FDA Approves First Treatment for Breast Cancer with a Certain Inherited Genetic Mutation

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast...

astrazeneca

LYNPARZA® (olaparib) Receives US FDA Approval for a New Indication

We are excited to announce on January 12, 2018, the FDA approved a new indication for the PARP inhibitor, LYNPARZA® (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy in the neoadjuvant, adjuvant...

astrazeneca

FDA approves AstraZeneca’s aparib for germline BRCA-mutated metastatic breast cancer

On January 12, 2018, the Food and Drug Administration granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic...

Announcing a New Indication for a PERJETA

Genentech is excited to share the news of the FDA approval of PERJETA in combination with trastuzumab and chemotherapy as: ·       Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast...

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