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LATEST DRUG UPDATES:

 

Info on accelerated approval for BRUKINSA

Please be aware NCCN has recently updated their Oncology Guidelines for Mantel Cell Leukemia (MCL) based on the accelerated approval for BRUKINSA. NCCN has provided BRUKINSA (zanubrutinib) in R/R MCL with a Level 2A Preferred evidence listing, comparable to other BTKi in the class. This is the link to the NCCN main website, https://www.nccn.org/professionals/physician_gls/default.aspx . 

Signatera Test to Assess Residual Disease

Signatera is a personalized, tumor informed circulating tumor DNA (ctDNA) test for molecular residual disease (MRD) assessment and surveillance monitoring. Signatera’s unique assay design is optimized to detect low levels of ctDNA with high sensitivity and specificity earlier than current colorectal cancer (CRC) standard of care. Signatera recently received Medicare draft coverage for certain forms...

astrazeneca

CALQUENCE® (acalabrutinib) Receives US FDA Approval for New Indication

The US Food and Drug Administration (FDA) has approved CALQUENCE® (acalabrutinib) capsules for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CALQUENCE for CLL was granted Breakthrough Therapy Designation by the FDA, and the approval was granted under the FDA’s Real Time Oncology Review (RTOR) and newly established...

BeiGene

Introducing BRUKINSA™ (zanubrutinib)—the new BTK inhibitor

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage For Immediate Release: November 14, 2019 Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma...

FDA Approved REBLOZYL® (luspatercept-aamt)

The US Food and Drug Administration has recently approved REBLOZYL® (luspatercept-aamt), the first and only erythroid maturation agent (EMA) indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require...

Alexion Receives FDA Approval For ULTOMIRIS® (Ravulizumab-Cwvz) For Atypical Hemolytic Uremic Syndrome (AHUS)

October 18, 2019 at 7:45 PM EDT PDF Version – At 26 weeks, 54% of adults and 71% of children treated with ULTOMIRIS demonstrated Complete Thrombotic Microangiopathy (TMA) Response – BOSTON–(BUSINESS WIRE)–Oct. 18, 2019– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the U.S. Food and Drug Administration (FDA) approved ULTOMIRIS® (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS)...

Genentech Access Solutions – Medicare Beneficiary Identifier (MBI) Update

Genentech Access Solutions – Medicare Beneficiary Identifier (MBI) Update This PDF provides important information about The Centers for Medicare & Medicaid (CMS) transition from the use of the Health Insurance Claim Number (HICN) to a Medicare Beneficiary Identifier (MBI) number, and how Genentech Access Solutions is addressing this conversion. Beginning January 1, 2020, Genentech Access...

CMS coverage changes regarding CAR T Therapies

Recently, the Centers for Medicare and Medicaid Services (CMS) posted two announcements which impacts payment and coverage  for Chimeric Antigen Receptor T-Cell (CAR T) Therapies.  This email will provide a brief summary of the Fiscal Year (FY) 2020 Inpatient Prospective Payment System (IPPS) Final Rule, and the National Coverage Determination (NCD) for CAR T cell therapy...

Celegene

Approval of a new product for myelofibrosis

Celgene is pleased to inform you of the US Food and Drug Administration’s recent approval of INREBIC® (fedratinib) capsules, a product from Celgene indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). Attached please find an announcement of this recent approval. http://cloud.info-celgene.com/inrebicpro INDICATION...

Announcing a New Genentech Therapy for ROS1+ mNSCLC and NTRK+ Solid Tumors

Dear Healthcare Professional:  Genentech is excited to share the news of a new FDA approval. ROZLYTREK™ (entrectinib) is now FDA approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. ROZLYTREK is also FDA approved for the treatment of adult and pediatric patients 12 years of age...

FDA Approves First Therapy for Rare Joint Tumor

The U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.   “TGCT can cause debilitating symptoms for patients such as pain, stiffness and limitation of movement....

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

On July 30, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy....

bayer health

FDA approves darolutamide for non-metastatic castration-resistant prostate cancer

On July 30, 2019, the Food and Drug Administration approved darolutamide (NUBEQA, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer. Approval was based on ARAMIS (NCT02200614), a multicenter, double-blind, placebo-controlled clinical trial in 1,509 patients with non-metastatic castration resistant prostate cancer. Patients were randomized (2:1) to receive either 600 mg darolutamide orally twice daily (n=955)...

pfizer

FDA approves Ruxience (rituximab-pvvr), biosimilar to Rituxan (rituximab)

The U.S Food and Drug Administration (FDA) today approved Ruxience (rituximab-pvvr), a biosimilar to U.S.-licensed 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, and CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with chemotherapy. Ruxience is also the...

FDA grants accelerated approval to selinexor for multiple myeloma

On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents,...

FDA approves selinexor for multiple myeloma

On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents,...

Change to the Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) J-code

Centers for Medicare & Medicaid Services (CMS) has made a change to the Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) J-code and has assigned a permanent J-code.  Effective July 1, 2019 the permanent J-code for Herceptin HYLECTA is J9356. If you have any questions, please reach out to me directly. You may also call Genentech Access Solutions at...

KEYTRUDA(R) (pembrolizumab): Additional Indication

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and...

pfizer

FDA approves Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab)

FDA approves Zirabev (bevacizumab-bvzr), a biosimilar to U.S.-licensed Avastin (bevacizumab).   A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms...

FLASCO Clinical Practice Committee – Making Strides for Patients

Recently, the FLASCO Clinical Practice Committee Chairman and Co-Chairmen, sent a letter to FL Blue expressing FLASCO’s  support for Gilotrif coverage. Last week Florida Blue provided the following response to FLASCO and we wanted to share this info with all members. “First of all thanks for reaching out to us and sharing feedback from FLASCO. ...

Recent update to the TECENTRIQ (atezolizumab) Prescribing Information

There was a recent update to the TECENTRIQ (atezolizumab) Prescribing Information that impacted the dosing regimens for certain indications. This change would allow for either the 840 mg or 1200 mg vials to be used for those indications. Please see below for the NDC information. Updated Prescribing Information Urothelial Carcinoma o   Administer TECENTRIQ as: 840...

FDA approves daratumumab for multiple myeloma ineligible for autologous stem cell transplant

On June 27, 2019, the Food and Drug Administration approved daratumumab (DARZALEX®, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Approval was based on MAIA (NCT02252172), an open-label, randomized (1:1), active-controlled phase 3 study, comparing dartumumab (16 mg/kg) in...

FDA Approves Amgen And Allergan’s KANJINTI™ (trastuzumab-anns),

Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. “The FDA approval of KANJINTI is an important milestone for our biosimilars portfolio, providing an additional treatment...

FDA approves pembrolizumab for metastatic small cell lung cancer

On June 17, 2019, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. Efficacy was investigated in 83 patients with SCLC who had disease progression on...

FDA granted accelerated approval to Polivy™

The FDA granted accelerated approval to Polivy™, Genentech’s fifth blood cancer medicine. Polivy (polatuzumab vedotin-piiq) is a first-of-its-kind anti-CD79b antibody-drug conjugate used in combination with bendamustine plus Rituxan (rituximab) for people with diffuse large B-cell lymphoma (DLBCL) whose disease returned after or did not respond to multiple treatment regimens. The Genentech press release including Important...

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