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 Sweden-based Oncopeptides’ Pepaxto, voting 14 “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 Oncopeptides first presented to…
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