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FDA Updates for November 2024
On November 20, 2024, the FDA granted accelerated approval to zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals, Inc.), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC) based on the HERIZON-BTC-01 trial (NCT04466891). The FDA also approved VENTANA PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic device to aid in identifying patients with BTC who may be eligible for treatment with Ziihera. Read More
On November 19, 2024, the FDA approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. Fludarabine Phosphate Injection is now approved as a component of a combination regimen for the treatment of adults with B-cell chronic lymphocytic leukemia (CLL), and for the treatment of adults with B-cell CLL who have not responded to or whose disease has progressed during treatment with at least one alkylating-agent containing regimen. Additional labeling revisions include a revised and updated dosage regimen to include the recommended dosage for use in combination with cyclophosphamide and rituximab, and the boxed warning was removed, and this information was incorporated in the Warnings and Precautions section. Read More
On November 15, 2024, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals, Inc.), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients 1 year and older based on the AUGMENT-101 trial (NCT04065399). Read More
On November 8, 2024, the FDA approved obecabtagene autoleucel (Aucatzyl, Autolus Inc.), a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) based on the FELIX trial (NCT04404660). Read More
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