Shots:

• The approval is based on the P-II  KarMMa trial that involves assessing Abecma in 127 patients with r/r MM prior treated with 3L+ therapy including an immunomodulatory agent- a proteasome inhibitor- and an anti-CD38 Ab
• Results: ORR (72%); sCR (28%); mDoR (11mos.); responses were rapid and durable- with a median time to response of 30 days (range: 15-88 days). The safety profile of Abecma is well-established and predictable including cytokine release syndrome and neurologic toxicities that are mostly low-grade with early-onset and resolution
• Abecma is a personalized immune cell therapy approved as a one-time infusion with a recommended dose range of 300 to 460 x 106 CAR-positive T cells

­ Ref: PRNewswire | Image: BMS