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26 Feb 2024
Admin
News Article

FDA Withdraws Accelerated Approval for Pepaxto

FDA uses new powers to pull Oncopeptides myeloma drug

Overview

The FDA announced its final decision to withdraw accelerated approval for Oncopeptides' drug Pepaxto (melphalan flufenamide), which was cleared in 2021 to treat patients with triple-class refractory multiple myeloma. Shares of Oncopeptides fell more than 20% on Friday.

Present Scenario

The company no longer actively markets Pepaxto in the US, but the withdrawal serves as an example of the FDA's willingness to use new powers enacted last year to swiftly reverse fast-tracked therapies if safety and efficacy ultimately remain unclear in follow-up studies.

Response from OCEAN study

Pepaxto's approval was contingent on a successful confirmatory trial demonstrating clinical benefit.
However, in the post-approval OCEAN study, the drug failed to improve overall survival compared to standard therapies and even showed an increased risk of death.
In 2022, an FDA advisory committee voted overwhelmingly against Pepaxto remaining on the market in light of the OCEAN data.
FDA official on withdrawal
Oncopeptides appealed the agency's initial proposal to withdraw approval, but Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, upheld the decision as final in a ruling on Friday.
Marks determined that the grounds for withdrawal have been met, as Pepaxto did not verify clinical benefit in the required confirmatory study, nor did it appear to be safe under its conditions of use.

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