ODAC gives a big thumbs-down to Oncopeptides' dangling accelerated approval in multiple myeloma
ODAC on Thursday voted overwhelmingly against keeping the accelerated approval for Oncopeptides’ Pepaxto, 14 voting “no,” and 2 “yes” to the FDA’s question of: “Is the benefit-risk profile of melphalan flufenamide favorable for the currently indicated patient population?”
It’s been more than 15 months since Sweden-based Oncopeptides first presented to the FDA its failed results from a confirmatory trial, known as OCEAN, following its 2021 accelerated approval of Pepaxto (melphalan flufenamide) as a fifth-line therapy for multiple myeloma.
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