11/19/2025

Recent Oncology Related FDA Approvals and Expanded Indications

FDA Approves Kura Oncology Inc.’s Komzifti™ (ziftomenib) for Relapsed or Refractory Acute Myeloid Leukemia with NPM1 Mutation

FDA Approves Johnson & Johnson’s DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for Patients with High-Risk Smoldering Multiple Myeloma

FDA Approves Syndax Pharmaceutical’s Revuforj® (revumenib) in Adult and Pediatric Patients with Relapsed or Refractory NPM1 Mutated Acute Myeloid Leukemia

FDA approves GlaxoSmithKline's Blenrep (belantamab mafodotin-blmf) for Relapsed or Refractory Multiple Myeloma

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