Pepaxto’s Accelerated Approval In Myeloma May Sink On OCEAN Trial's Adverse Survival Data
US FDA is reviewing confirmatory trial data that suggest a ‘detriment in survival’ with Oncopeptides’ alkylating agent in relapsed/refractory multiple myeloma and may convene its Oncologic Drugs Advisory Committee to explore continued marketing for patients who received at least four prior lines of therapy.
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239 Days: Oncopeptides' Myeloma Drug Pepaxto Comes Off Market Just Months After Accelerated Approval
Withdrawal announcement marks shortest interval ever from accelerated approval to market removal after OCEAN confirmatory trial showed an adverse overall survival trend and US FDA said a hypothesis-generating subgroup analysis would need to be borne out in another study.
The oncologic drugs advisory committee’s upcoming reviews are moving beyond the PD-1/PDL-1 inhibitor class – and to a very different type of sponsor.
User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.