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Oncopeptides Weighing Pepaxto Withdrawal Request

Executive Summary

Drama continues for the multiple myeloma treatment as US FDA formally moves to pull accelerated approval. Oncopeptides anticipates making a decision on the request in the first quarter of 2023.

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Accelerated Approval: Oncopeptides' Pepaxto Will Test New Expedited Withdrawal Process

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.

Status Quo: US Approvals For Pepaxto, Copiktra Remain Intact Despite Negative Panel Reviews

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.

Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps

Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.

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