Bristol Myers, 2seventy Bio’s Abecma approved by U.S. FDA

Bristol Myers Squibb (BMY) and 2seventy bio (TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration, FDA, approved Abecma for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial. This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment, after two prior lines of therapy. Abecma is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells. “We are extremely pleased that Abecma will be available to many more patients in the U.S.,” said Chip Baird, chief executive officer, 2seventy bio. “This approval represents another important milestone for patients, for Abecma, and for 2seventy bio as we remain committed to increasing treatment options and working to improve outcomes for patients living with multiple myeloma.”