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# FDA Urges Oncopeptides to Withdraw Multiple Myeloma Drug
- URL: https://www.fdaweb.com/fda-urges-oncopeptides-to-withdraw-multiple-myeloma-drug/
- Published: 2022-12-07T12:00:00.000Z
- Updated: 2026-09-14T18:08:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153344

FDA has asked Oncopeptides to withdraw the accelerated NDA approval for multiple myeloma therapy Pepaxto (melphalan flufenamide) after a confirmatory trial (OCEAN) demonstrated a worse overall survival and failed to verify clinical benefit. The request is more evidence ([see earlier story](https://www.fdaweb.com/fda-seeks-new-accelerated-approval-requirement/)) that the agency is holding industry to timely completion of required confirmatory studies and to act accordingly when such studies fail to meet their endpoints.

Pepaxto was originally approved 2/2021, and at FDA’s request, Oncopeptides ceased marketing the therapy 10/2021, the company says. The withdrawal request comes two and a half months after FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 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/)). It dismissed the company’s revised PFS that showed a marginal PFS significance because it considered unconfirmed progression as events in the PFS analysis.

“The results of analyses of other efficacy endpoints such as ORR \[objective response rate\] and DOR \[duration of response\] were either not statistically significant or provided for a magnitude of effect that would not be considered clinically meaningful, the agency continued. “The results from the OCEAN trial demonstrated a detriment in overall survival for the melphalan flufenamide arm. The safety data indicate that the worse OS \[overall survival\] results are indicative of a safety concern and suggest a potential for harm with melphalan flufenamide.”