The accelerated approval of Oncopeptides AB’s Pepaxto (melphalan flufenamide, or melflufen) should be withdrawn because a confirmatory study failed to verify clinical benefit and the available evidence demonstrates the multiple myeloma drug is not shown to be safe and effective under its conditions of use, the US Food and Drug Administration said.
Accelerated Approval: US FDA’s Hammer Falls On Oncopeptides’ Pepaxto
Rejecting company’s appeal, CBER Director Peter Marks says the multiple myeloma drug should be withdrawn because its confirmatory trial failed to verify clinical benefit and evidence demonstrates the drug is not safe and effective for its current indication.
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