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.
To Save Pepaxto, Oncopeptides Throws Shade At IMiD Use In Elderly Myeloma Patients
Seeking to head off US FDA withdrawal of its alkylating agent, sponsor says pomalidomide comparator in OCEAN confirmatory trial rendered overall survival results difficult to interpret because immunomodulatory drugs are detrimental in elderly patients. CDER says IMiD analysis is exploratory and cannot negate adverse overall survival finding with Pepaxto.
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