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Home » FDA Seeks Public Comment on Withdrawal of Pepaxto Accelerated Approval
FDA Seeks Public Comment on Withdrawal of Pepaxto Accelerated Approval
The FDA is seeking public comment on its decision to withdraw accelerated approval for Oncopeptide’s Pepaxto (melphalan flufenamide), after a required postmarketing study showed that the drug plus dexamethasone failed to improve progression-free survival in patients with relapsed or refractory multiple myeloma.