Category: FDA Approval
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On November 18, 2025, the US Food and Drug Administration approved epcoritamab-bysp in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (FL). On the same day, the FDA also converted the prior accelerated approval of epcoritamab-bysp monotherapy in patients with FL who have received at least two prior lines…
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On November 13, 2025, the US Food and Drug Administration approved the menin inhibitor ziftomenib (Komzifti) for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring a susceptible NPM1 mutation and for whom no satisfactory alternative treatments are available. The approval was based on the phase 1/2 KOMET-001 trial (NCT04067336), an open-label, multicenter…
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On November 13, 2025, the US Food and Drug Administration approved pertuzumab-dpzb (Poherdy) as an interchangeable biosimilar to pertuzumab (Perjeta) for the treatment of HER2-positive breast cancer, consistent with the indications of the reference product. The approval was based on analytical, nonclinical, and clinical data establishing biosimilarity and interchangeability with the reference product. Evidence included…