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Pepaxto Adcom Saw Public Airing Of Unusual Level Of Discord Between US FDA, Oncopeptides

 
• By Sue Sutter

The four-hour virtual public meeting featured "incompatible" views of the FDA and sponsor on the OCEAN data, not to mention signs of impatience and resentment, with each side criticizing the positions of the other over the safety and efficacy of the multiple myeloma drug.

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The FDA and Oncopeptides seemed to agree on little at the recent ODAC meeting on Pepaxto. • Source: Shutterstock

US Food and Drug Administration advisory committee meetings often can be dull affairs, with the product sponsor and agency reviewers methodically presenting their analyses of the data at hand before the FDA’s external experts discuss and vote on the matter.

However, the Oncologic Drugs Advisory Committee’s recent re-evaluation of the benefit-risk profile for Oncopeptides AB’s alkylating agent Pepaxto (melphalan flufenamide, or melflufen) in its current accelerated approval indication for...

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