Oncopeptides Rescinds Pepaxto Voluntary Withdrawal, Which Could Set Up Battle With US FDA
After more review of clinical trial data, the myeloma drug’s sponsor wants to talk to the FDA again, but Oncopeptides execs said they cannot disclose the scientific details that led to the decision.
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How Fast Is ‘Expedited’? Pepaxto To Show Speed Of New Withdrawal Process For Accelerated Approval Drugs
For the Pepaxto appeal to be wrapped up on a faster timeline than Genentech’s dispute with the US FDA drugs center over Avastin’s breast cancer claim, CBER Director Peter Marks, the commissioner’s designee, would have to render a final decision before January 2024.
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.
More than seven months after the Oncologic Drugs Advisory Committee voted that Pepaxto and Copiktra had negative benefit-risk profiles in their labeled indications, the drugs' approvals remain intact. Oncopeptides is still considering whether to heed the FDA's request to withdraw the Pepaxto NDA, even though the drug is not currently marketed. Secura Bio says Copiktra remains on the market and available for prescribing.