Managed Healthcare Executive February 24, 2024
The FDA has removed the approval of Pepaxto in multiple myeloma. The agency approved Amtagvi, the first TIL therapy for a solid tumor, as well a new biweekly dosing of Tecvayli for multiple myeloma. The agency has set actions for several products, including a first-in-class lung cancer therapy, a bispecific antibody for advanced multiple myeloma, and another for Dupixent for COPD
FDA Withdraws Approval of Pepaxto in Multiple Myeloma
The FDA has withdrawn the approval of Oncopeptides’ Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. The final decision was issued by FDA’s Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D.
Regulators indicated that the confirmatory study...
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