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New Accelerated Approval Withdrawal Process More Streamlined, Marks Says

 
• By Derrick Gingery

OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.

multiple myeloma
Pepaxto is the third product that used accelerated approval to gain market entry and then be withdrawn through FDA regulation. • Source: Shutterstock

The withdrawal of Pepaxto, the first to use a new streamlined pathway, was much less agonizing than prior efforts to remove products that had received accelerated approval over the objections of the sponsor, according to Peter Marks, director of the US Food and Drug Administration Center for Biologics Evaluation and Research.

Marks, who was the designed FDA official in charge of the formal withdrawal of the multiple myeloma treatment, said the new process mandated by the 2022 Food and Drug Omnibus Reform Act

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