By Colin Kellaher


Shares of 2seventy bio rose more than 30% in premarket trading Monday after a Food and Drug Administration advisory committee meeting backed the expanded use of Abecma, the gene therapy it sells with partner Bristol Myers Squibb.

After the closing bell on Friday, 2seventy and Bristol said the panel voted 8-3 that Abecma showed a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from a pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival.

Briefing documents released last week ahead of the meeting showed the FDA had some concerns about a higher rate of early deaths in patients receiving Abecma in the study, which was aimed at winning approval for earlier use of the gene therapy in the treatment course for people with the blood cancer multiple myeloma.

Bristol and 2seventy said the FDA will consider the committee's recommendation as the agency continues its review of the application. The FDA usually follows the advice of its advisory committees, but it isn't bound by the recommendations.

The FDA had been slated to act on the application in December but instead opted to hold the advisory committee meeting, and the companies on Friday said the agency hasn't yet set a new target action date.

Abecma is currently approved by the FDA for adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

Shares of 2seventy, which closed Friday at $4.01, were recently up 32% to $5.28 in premarket trading, while shares of Bristol, which ended Friday's session at $52.34, were unchanged.


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


(END) Dow Jones Newswires

03-18-24 0614ET