Oncopeptides AB’s argument against US Food and Drug Administration withdrawal of its akylating agent Pepaxto (melphalan flufenamide, or melflufen) rests upon what it says are the shortfalls in efficacy and safety with another class of drugs used to treat elderly multiple myeloma patients.
Key Takeaways
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Oncopeptides says Pepaxto’s accelerated approval should not be withdrawn because the OCEAN overall survival results were complicated by use of pomalidomide, an immunomodulatory drug, as a comparator.
In its written appeal of the Center for Drug Evaluation and Research’s proposal to withdraw accelerated approval, Oncopeptides said...
