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On February 23, 2024, the FDA announced its decision to withdraw this approval. The withdrawal was due to the confirmatory study's failure to verify clinical benefit, and the available evidence did not demonstrate the drug's safety and effectiveness under its prescribed conditions of use.
The European Commission granted marketing authorization for melphalan flufenamide, marketed as Pepaxti, in the EU on August 17, 2022. This authorization allows its use in combination with dexamethasone for adults with multiple myeloma. The approved EU population includes patients who have received at least three prior lines of therapy and are refractory to a proteasome inhibitor, an immunomodulatory agent, and an anti-…