Industry News

The following section is additional information posted from our Corporate members to supplement product announcements.

• Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code for POLIVY™ (polatuzumab vedotin-piiq). POLIVY received FDA approval on June 10, 2019: Click here for more.
• Find out how Taiho Oncology is making access easier for patients. Click here for more.
• Pfizer Inc. has partnered with Triage Cancer to provide a guide to help patients in selecting the best Medicare Plan: Quick Guide to Health Insurance: Medicare.
• Patient support for Pfizer products RETACRIT (epoetin alfa-epbx) and NIVESTYM (filgrastim-aafi) will transfer from Pfizer enCompass to Pfizer Oncology Together effective October 1, 2019. Pfizer is committed to supporting patients throughout their treatment journey and making this a seamless transition for patient support. With Pfizer Oncology Together, patients prescribed a Pfizer Oncology medication get personalized support, including help identifying financial assistance options and connections to resources that may help with some of their day‐to‐day challenges. Visit PfizerOncologyTogether.com for more details.
• Pfizer Inc. is pleased to announce that new safety information has been added to the labeling for all  CDK4/6 Inhibitors, including IBRANCE. Section 5.2 Warnings and Precautions includes additional information.
• New Packaging Configuration for KEYTRUDA
• Merck is pleased to announce that KEYTRUDA, as a single agent, has been approved by the FDA for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or metastatic NSCLC, and whose tumors express PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
• The National Comprehensive Cancer Network© (NCCN©) has updated the Clinical Practice Guidelines in Oncology for Colon and Rectal Cancer to include BRAFTOVI® in combination with MEKTOVI® and cetuximab or panitumumab as a Category 2a treatment for patients with BRAFV600E-mutant metastatic colorectal cancer (mCRC), after failure of one to two prior lines of therapy for metastatic disease.
• FDA Grants Genentech's Tecentriq in Combination With Abraxane Accelerated Approval for People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
• FDA Approves Taiho Oncology's LONSURF® (trifluridine/tipiracil) for Adult Patients with Previously Treated Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

• AZ Oncology ID is your resource for biomarker testing to help patients receive the most appropriate, personalized treatment.

•  

  AbbVie Announces U.S. FDA Approval of IMBRUVICA® (ibrutinib) Plus Obinutuzumab (GAZYVA®) – First Chemotherapy-Free, Anti-CD20 Combination Regimen Approved for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) in Previously Untreated Patients
• AstraZeneca and Merck & Co., Inc., today announced that the US Food and Drug Administration (FDA) has approved LYNPARZA for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy.
• Astellas Pharma US, Inc. is pleased to announce that the FDA has approved XOSPATA. XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. Click here for more.  Click here for safety information.  Click here for prescribing information.

• Gennetech - 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).  Click here for more.

• Genentech announced the FDA granted accelerated approval to Venclexta® (venetoclax), in combination with a hypomethylating agent (azacitidine or decitabine), or low dose cytarabine (LDAC), for the treatment of people with newly-diagnosed acute myeloid leukemia (AML), who are age 75 years or older, or for those ineligible for intensive induction chemotherapy due to coexisting medical conditions. The Genentech press release including Important Safety Information is linked here.  Click here for prescribing information.