TSVT 2seventy bio Inc

By Colin Kellaher

A U.S. Food and Drug Administration decision on the approval of earlier use of the Abecma gene therapy from Bristol Myers Squibb and 2seventy bio has been pushed back after the agency opted to hold an advisory committee meeting to review data supporting the application.

Bristol Myers and 2seventy on Monday said the FDA hasn't yet confirmed the date of the meeting but has informed the companies that the agency won't decide on the application by its target action date of Dec. 16.

The FDA often turns to advisory committees to obtain advice from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective. The agency usually follows the advice of its advisory committees, but it isn't bound by the recommendations.

Bristol Myers and 2seventy are seeking FDA approval for earlier use of Abecma in the treatment course for people with the blood cancer multiple myeloma.

The companies' application is based on a Phase 3 study in which Abecma significantly reduced the risk of disease progression or death versus standard regimens in adults with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.

Bristol Myers and 2seventy on Monday said they expect the FDA advisory committee will review data related to the study's secondary endpoint of overall survival.

New York-based Bristol Myers and 2seventy, a Cambridge, Mass., biotechnology company, are jointly developing and commercializing Abecma in the U.S., with Bristol responsible for manufacturing and commercialization outside of the U.S.

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

(END) Dow Jones Newswires

November 20, 2023 07:41 ET (12:41 GMT)

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