Bristol Myers, 2seventy Bio's Cancer Drug Wins Approval From FDA Committee

By Ben Glickman


Bristol Myers Squibb and 2seventy Bio's cancer treatment showed a favorable risk-benefit profile in certain populations, according to Food and Drug Administration committee.

The Oncologic Drugs Advisory Committee voted 8-3 that Abecma, a gene therapy, had a favorable profile in the treatment of the blood cancer multiple myeloma, specifically in the triple-class exposed relapsed or refractory forms of the cancer, the companies said on Friday.

Bristol Myers Squibb and 2seventy said the recommendation would be considered by the FDA in its review of their supplemental Biologics License Application.

The FDA hasn't assigned a new target action date for reviewing that application, the companies said.

Abecma was recently approved in Japan and Switzerland for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies.


Write to Ben Glickman at ben.glickman@wsj.com

(END) Dow Jones Newswires

03-15-24 1904ET