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# Oncopeptides Appealing Drug Withdrawal Request
- URL: https://www.fdaweb.com/oncopeptides-appealing-drug-withdrawal-request/
- Published: 2023-08-15T12:00:00.000Z
- Updated: 2026-09-14T18:50:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155106

Oncopeptides says it is going to file a formal appeal of FDA’s recent request for the company to voluntarily withdraw its accelerated-approved multiple myeloma drug Pepaxto (melphalan flufenamide). This looks to be the first test of the modified authority FDA was granted late last year under the Food and Drug Omnibus Reform Act (FDORA) as part of an omnibus spending bill. For example, highly anticipated accelerated-approval modifications were included in Sec. 3210 Modernizing Accelerated Approval, such as “expedited procedures” it can take to force an accelerated-approval product from the market when a drug sponsor’s confirmatory data fail to demonstrate a clinical benefit.

FDA’s request to withdraw the drug came after a confirmatory trial (OCEAN) demonstrated a worse overall survival and failed to verify clinical benefit. Pepaxto was originally approved 2/2021, and at FDA’s request, Oncopeptides ceased marketing the therapy 10/2021, the company says. The withdrawal request follows a 9/23/2022 Oncologic Drugs Advisory Committee (ODAC) vote of 14 to 2 against whether the benefit-to-risk profile of Pepaxto was favorable in adult patients with relapsed or refractory multiple myeloma.

In a [briefing document](https://www.fda.gov/media/161678/download?ref=fdaweb.com) released in advance of the meeting, FDA reviewers said the OCEAN trial did not meet the prespecified primary endpoint — progression-free survival (PFS) superiority of melphalan flufenamide compared to pomalidomide ([see story](https://www.fdaweb.com/agency-questions-confirmatory-study-for-pepaxto/)). FDA dismissed revised PFS data the company submitted showing a marginal PFS significance because it considered unconfirmed progression as events in the PFS analysis.