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FDA Withdraws Approval of Pepaxto


In a recent posting on its website, the FDA stated that it has made a final determination to withdraw the approval of Pepaxto. The grounds for this decision include Oncopeptides’ failure to confirm the drug’s clinical benefit in a required confirmatory study. Additionally, the available evidence indicates that Pepaxto is not proven to be safe or effective under its designated conditions of use.

Background Information

Initially granted accelerated approval in February 2021, Pepaxto was intended for patients with multiple-myeloma, a type of blood cancer that had relapsed after at least four prior treatments. Oncopeptides ceased the sale of Pepaxto in the U.S. in October of the same year following unsatisfactory results from the necessary confirmatory study.

FDA Advisory Committee Vote

In September 2022, an FDA advisory committee voted 14 to 2 that the benefits of Pepaxto do not outweigh its risks. Many advisors expressed concerns aligning with the FDA’s view that the drug could potentially have a negative impact on patients’ survival rates.

Oncopeptides’ Response

Market Impact

Following the news, shares of Oncopeptides experienced a more than 20% decline on Friday, closing at SEK6.00 by the end of the day.

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