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# Comments Sought on Pepaxto’s Proposed Withdrawal
- URL: https://www.fdaweb.com/comments-sought-on-pepaxtos-proposed-withdrawal/
- Published: 2023-08-25T12:00:00.000Z
- Updated: 2026-09-14T18:52:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155182

CDER is seeking [comments](https://www.govinfo.gov/content/pkg/FR-2023-08-25/pdf/2023-18320.pdf?ref=fdaweb.com) on its proposal to withdraw Oncopeptides’ accelerated-approved multiple myeloma drug Pepaxto (melphalan flufenamide). The proposal 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 it 10/2021, the company says.

The withdrawal request also 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.