The US Food and Drug Administration (FDA) has granted an indication extension for Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T therapy Abecma (idecabtagene vicleucel), approving it for use in adult patients with triple-class exposed relapsed or refractory multiple myeloma (r/rMM) who have received two or more prior lines of therapy. Previously, the BCMA-targeted treatment was indicated for patients who had undergone four or more prior lines of therapy.
The approval comes on the heels of a successful late-stage trial that demonstrated Abecma’s efficacy in improving progression-free survival (PFS), a primary endpoint. The trial showed that a one-time infusion of Abecma reduced the risk of disease progression or death by 51% compared to standard therapies. Moreover, it increased the overall response rate to 71% from 42% in the control group, highlighting the therapy’s potential to significantly benefit patients with r/rMM.
Abecma has also shown a well-established safety profile, which adds to its appeal as a treatment option for patients with r/rMM. Bristol Myers Squibb has reported a 94% manufacturing success rate for Abecma and has made significant investments to increase its manufacturing capacity. This move is set to ensure that more patients have access to this innovative therapy, which is poised to change the treatment landscape for multiple myeloma.- Flcube.com
