News Briefs: FDA Requests Withdrawal of Pepaxto Marketing Authorization

The FDA has requested that Oncopeptides AB withdraw the U.S. marketing authorization for Pepaxto (melphalan flufenamide), the company revealed on Dec. 7. “We respect FDA´s accelerated approval regulations,” said CEO Jakob Lindberg in a statement. The FDA initially gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. But then on Oct. 22, 2021, the company requested voluntary withdrawal of the peptide-drug conjugate’s New Drug Application (NDA). That was followed early in 2022 by Oncopeptides’ rescinding the letter requesting the NDA’s withdrawal based on “further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study and other relevant trials.” On Sept. 22, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) held a meeting to assess the drug’s risk/benefit profile; it voted 14-2 that the drug is not favorable for adults with relapsed or refractory multiple myeloma. Oncopeptides is commercializing the therapy in Europe, where it is known as Pepaxti, following its full approval on Aug. 18, 2022.

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