By Colin Kellaher


The Food and Drug Administration has officially pulled its authorization of the anticancer drug Pepaxto from Swedish biotech Oncopeptides.

In a posting on its website Friday, the FDA said it reached a final determination that the grounds for withdrawing the approval have been met because the confirmatory study that Oncopeptides conducted as a condition of the 2021 accelerated green light didn't confirm Pepaxto's clinical benefit, and that available evidence demonstrates the drug isn't shown to be safe or effective under its conditions of use.

The FDA in February 2021 granted accelerated approval to Pepaxto for patients with the blood cancer multiple-myeloma whose cancers relapsed after at least four different prior treatments were tried.

Oncopeptides stopped selling the drug in the U.S. in October of that year after disappointing results from a confirmatory study required under the accelerated approval, and the agency and company had been at odds since over the drug's fate.

An FDA advisory committee in September 2022 voted 14 to 2 that Pepaxto's benefits don't outweigh its risks, with many advisers agreeing with the FDA's concerns that the drug might have a negative effect on patients' survival.

Oncopeptides said it will thoroughly assess the FDA's decision, adding that its focus remains on commercialization in Europe, where the company has a full marketing authorization of the drug under the name Pepaxti.

Shares of Oncopeptides fell more than 20% on Friday to end the day at SEK6.00


Write to Colin Kellaher at colin.kellaher@wsj.com


(END) Dow Jones Newswires

02-23-24 1309ET