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Eight FDA updates

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The FDA has announced several decisions and opinions related to hematology and oncology in the past month.

HemOnc Today summarizes eight FDA actions that may be relevant to your practice.

• The Oncologic Drugs Advisory Committee (ODAC), an FDA advisory panel, supported approval of Pfizer’s biosimilar version of Amgen’s epoetin alfa for the treatment of anemia from various causes. Read more.
• The FDA granted priority review to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of patients with hepatocellular carcinoma who were previously treated with sorafenib (Nexavar, Bayer). Read more.
• ODAC expressed its support for the approval of L-glutamine powder (Emmaus Medical) in the treatment of sickle cell disease. Read more.
• ODAC largely expressed its support for the approval of neratinib (Nerlynx, Puma Biotechnology) in the adjuvant treatment of early-stage HER-2–positive breast cancer. Read more.
• The FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) for adults and children with unresectable or metastatic, microsatellite instability–high or mismatch repair–deficient solid tumors. Read more.
• The FDA granted accelerated approval to avelumab (Bavencio, EMD Serono) for the treatment of 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 platinum-containing chemotherapy. Read more.
• The FDA granted accelerated approval to durvalumab (Imfinzi, AstraZeneca) for the treatment of patients with locally advanced or metastatic urothelial carcinoma. The agency also approved the VENTANA PD-L1 Assay (SP263, Ventana Medical Systems) as a complementary diagnostic for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue. Read more.
• The FDA granted accelerated and regular approval to pembrolizumab (Keytruda, Merck) for the first- and second-line treatments of locally advanced or metastatic urothelial carcinoma. Read more.