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astrazeneca

Reimbursement Update Permanent J code for Imfinzi

IMFINZI is indicated for the treatment of patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.  The NEW Permanent J-Code is J91731 and goes into effect January 1, 2019.

ASH 2018 News From Genentech

This year at the American Society of Hematology (ASH) Annual Meeting, Genentech presented data for ten medicines in more than 70 abstracts, including 25 oral presentations [press release]. Highlighted data included new data from three Venclexta® (venetoclax) combination studies demonstrating deep responses in chronic lymphocytic leukemia and acute myeloid leukemia, two of the most common types...

Entrinsic Health Solutions and Markey Cancer Center Launch Phase II Study for Neuroendocrine Tumor Patients with Quality of Life-Limiting Diarrhea

NORWOOD, Mass., Dec. 12, 2018 /PRNewswire/ — Entrinsic Health Solutions in partnership with the University of Kentucky (UK) Markey Cancer Center today announced initiation of active accrual and first consented patient in its Phase II study evaluating enterade® – a glucose-free, medical food – in neuroendocrine tumor and carcinoid syndrome patients. Findings from this study may show that enterade can...

Permanent J-codes for Genentech Hematology Products

 The Centers for Medicare & Medicaid Services (CMS) has made a change to the RITUXAN® (rituximab) J-code and has assigned a permanent J-code for RITUXAN HYCELA® (rituximab/hyaluronidase human subcutaneous injection). Effective January 1, 2019 J-code J9312 will replace J9310 for RITUXAN and the billable units will change from 100 mg to 10 mg. Additionally, the...

C-code for ONPATTRO™ (patisiran) lipid complex injection

We are sending this communication on behalf of Alnylam Pharmaceuticals, Inc., to announce the assignment of a product‐specific temporary C-code for ONPATTRO™ (patisiran) lipid complex injection, for intravenous use. The Centers for Medicare & Medicaid Services (CMS) released the 2019 Alpha-Numeric HCPCS File, which included the designation of C9036, Injection, patisiran, 0.1 mg for ONPATTRO with the...

New Launch of Product Xospata

Astellas is pleased to announce the product approval of XOSPATA (gilteritinib). For details on the indication for XOSPATA, please reference the attached PDF

New indication for VENCLEXTA(R) (venetoclax tablets)

On November 21, 2018, VENCLEXTA® (venetoclax tablets) was approved by the US Food and Drug Administration (FDA) in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy....

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

The U.S. Food and Drug Administration approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of...

FDA approves Bayer’s larotrectinib for solid tumors with NTRK gene fusions

On November 26, 2018, the Food and Drug Administration granted accelerated approval to larotrectinib (VITRAKVI, Loxo Oncology Inc. and Bayer) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, that are either metastatic or where surgical resection is likely to...

The antidiarrheal efficacy of a proprietary amino acid mixture in neuroendocrine tumor (NET) patients.

Clinical data for neuroendocrine tumor patients. Entrinsic recently presented data at ASCO’s Palliative and Supportive Care in Oncology Symposium. Updated clinical results showed that 80% of NET patients reported reduction in diarrhea frequency using enterade. In addition,51% of patients reported more than 50% reduction in frequency. Diarrhea is the most common and debilitating symptom among NET cancer patients. Please...

FDA Grants Breakthrough Therapy Designation to ADCETRIS® (Brentuximab Vedotin) for Frontline Peripheral T-Cell Lymphomas

FDA Grants Breakthrough Therapy Designation to ADCETRIS® (Brentuximab Vedotin) for Frontline Peripheral T-Cell Lymphomas   -Designation Based on Positive Phase 3 ECHELON-2 Trial Evaluating ADCETRIS in Frontline CD30-Expressing Peripheral T-Cell Lymphomas; Data to be Presented at Upcoming American Society of Hematology Annual Meeting in December- BOTHELL, Wash. – November 15, 2018 – Seattle Genetics, Inc....

FDA approves brentuximab vedotin for previously untreated sALCL and CD30-expressing PTCL

On November 16, 2018, the Food and Drug Administration approved brentuximab vedotin (ADCETRIS, Seattle Genetics Inc.) in combination with chemotherapy for previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified. This is the first FDA approval for previously untreated PTCL...

FDA approves emapalumab for hemophagocytic lymphohistiocytosis

On November 20, 2018, the Food and Drug Administration approved emapalumab (GAMIFANT, Novimmune SA), a monoclonal antibody that binds and neutralizes interferon gamma, for adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Approval was based on a multicenter, open-label,...

FDA Approves Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

On November 6, the U.S. Food and Drug Administration (FDA) approved elotuzumab (Empliciti) injection for intravenous use in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide (Revlimid) and a proteasome inhibitor. In ELOQUENT-3, a randomized, open-label, phase II trial, elotuzumab...

FDA grants accelerated approval to pembrolizumab for hepatocellular carcinoma

On November 9, 2018, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. For additional information, please click here. Approval was based on KEYNOTE 224 (NCT02702414), a single-arm, multicenter trial enrolling 104 patients with hepatocellular carcinoma....

Merck is pleased to announce that KEYTRUDA in combination with carboplatin and either paclitaxel or nab-paclitaxel has been approved by the FDA for the first-line treatment of patients with metastatic squamous NSCLC

KEYTRUDA is also indicated in combination with pemetrexed and platinum chemotherapy for the ·    First-line treatment of patients with metastatic nonsquamous NSCLC, with no EGFR or ALK genomic tumor aberrations KEYTRUDA is also indicated as a single agent for the ·    First-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (TPS ≥50%) as...

astrazeneca

NCCN Guidelines Osimertinib (TAGRISSO) Upate

Osimertinib (TAGRISSO®) is now the only preferred first-line EGFR TKI in the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®). I am excited to share with you that first-line Osimertinib (TAGRISSO®) has been elevated to preferred status in the NCCN Guidelines®, for sensitizing EGFR mutation-positive metastatic NSCLC. Osimertinib’s (TAGRISSO®) preferred status among all Category 1 recommended EGFR...

U.S. Food and Drug Administration Approves Empliciti® (elotuzumab) Plus Pomalidomide and Dexamethasone, a New Immunotherapy Combination for Certain Patients with Relapsed or Refractory Multiple Myeloma

In the ELOQUENT-3 trial, treatment with Empliciti plus pomalidomide and dexamethasone (EPd) doubled median progression-free survival and overall response rate versus pomalidomide and dexamethasone (Pd) 1 Low discontinuation rates due to adverse reactions were observed with both EPd and Pd alone 1 Empliciti, when used in combination with pomalidomide and dexamethasone, can be administered once monthly after first two cycles 1 TUESDAY,...

FDA approved Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim).

After previous US regulatory setbacks, Coherus Biosciences has gained FDA approval for its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv). The biosimilar, referencing Neulasta, has been approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia. The company will provide more details on pricing and...

pfizer

FDA approves lorlatinib for second- or third-line treatment of ALK-positive metastatic NSCLC

On November 2, 2018, the Food and Drug Administration granted accelerated approval to lorlatinib (LORBRENA, Pfizer, Inc.) for patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib...

spectrum

Spectrum Pharmaceuticals Receives FDA Approval of KHAPZORY™ (levoleucovorin) for injection

Spectrum Pharmaceuticals, Inc.(NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved KHAPZORY (levoleucovorin) for injection, a folate analog for three indications: • Rescue after high-dose methotrexate therapy in patients with osteosarcoma. • Diminishing...

pfizer

FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer

On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib. Approval was based on...

pfizer

U.S. FDA Approves VIZIMPRO® (dacomitinib) for the First-Line Treatment of Patients with EGFR-Mutated Metastatic Non-Small Cell Lung Cancer

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved VIZIMPRO® [vih-ZIM-pro] (dacomitinib), a kinase inhibitor for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an...

FDA approves new drug for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis

The US Food and Drug Administration (FDA) approved Tegsedi (inotersen), an antisense oligonucleotide (ASO) that inhibits the production of the transthyretin (TTR) protein (amyloid), for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR) in adults. This is the second FDA approved drug for hATTR. Onpattro (patisiran), was the first treatment approved for this...

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