FDA Withdraws Accelerated Approval for Pepaxto

FDA Withdraws Accelerated Approval for Pepaxto

By, Admin 26 February 2024

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!