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Accelerated Approval: Oncopeptides' Pepaxto Will Test New Expedited Withdrawal Process

 
• By Sue Sutter

Company’s appeal of the US FDA’s formal request to voluntarily withdraw accelerated approval of the multiple myeloma agent is expected to follow the streamlined procedures created in last year’s omnibus legislation, which would preclude a second advisory committee review of melflufen’s fate.

Feet in ocean
A dispute over interpretation of the OCEAN trial data is at the heart of Oncopeptides' decision to test the waters of US FDA's new expedited withdrawal procedures. • Source: Shutterstock

It appears that Oncopeptides AB will be the first drug sponsor to test the US Food and Drug Administration’s new expedited procedures for accelerated approval withdrawal as it appeals an agency request to pull the new drug application for Pepaxto (melphalan flufenamide, or melflufen).

In a 10 August second quarter earnings announcement, Oncopeptides said that in July the company received a formal request from the FDA to voluntarily withdraw approval of the multiple myeloma

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