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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The US FDA is free from the need to reconsider Accelerated Approvals in a formal hearing in front of an advisory committee. But now the agency is now trying that approach to hear an appeal of a rejected application.
FDA’s Pepaxto Decider: Peter Marks To Handle Oncopeptides’ Appeal Of Accelerated Approval Withdrawal
CBER director will decide whether the multiple myeloma drug should be withdrawn under new expedited withdrawal procedures; it's the third time FDA leaders have asked senior officials in the biologics center to help decide the fate of a CDER-regulated accelerated approval drug.
Company’s appeal of the US FDA’s formal request to voluntarily withdraw accelerated approval of the multiple myeloma agent is expected to follow the streamlined procedures created in last year’s omnibus legislation, which would preclude a second advisory committee review of melflufen’s fate.