To Save Pepaxto, Oncopeptides Throws Shade At IMiD Use In Elderly Myeloma Patients
Executive Summary
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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