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239 Days: Oncopeptides' Myeloma Drug Pepaxto Comes Off Market Just Months After Accelerated Approval

 
• By Sue Sutter

Withdrawal announcement marks shortest interval ever from accelerated approval to market removal after OCEAN confirmatory trial showed an adverse overall survival trend and US FDA said a hypothesis-generating subgroup analysis would need to be borne out in another study.

Sinking ship
An adverse survival trend in a confirmatory trial sank Pepaxto's chances of remaining on the market • Source: Alamy

Oncopeptides AB’s decision to pull the multiple myeloma drug Pepaxto (melphalan flufenamide) off the US market due to an adverse survival trend in the OCEAN confirmatory trial sets a new record for fastest time from US Food and Drug Administration accelerated approval to withdrawal.

The drug’s withdrawal was announced by Oncopeptides just 239 days after its accelerated approval in a heavily pretreated population of multiple myeloma patients

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