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 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.
The FDA sounded no closer on Thursday to coming around on the company’s re-analyzed benefits too, and several ODAC members expressed serious reservations.
ODAC panelist Andy Chen of Oregon Health & Science University questioned the negative overall survival benefit in announcing his “no” vote, while Anthony Sung of Duke University said he didn’t think the benefit outweighs the risks.
The road has been rocky and unorthodox one for Oncopeptides, which nearly a…
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