The FDA has granted accelerated approval to elranatamab-bcmm (Elrexfio) for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously received at least 4 lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

The regulatory decision is supported by data from the phase 2 MagnetisMM-3 trial (NCT04649359), which showed that elranatamab elicited an overall response rate (ORR) of 57.7% (95% CI, 47.3%-67.7%) in the 97 patients who were naïve to BCMA-directed therapy; this included a complete response (CR) rate of 25.8%, a very good partial response (VGPR) rate of 25.8, and a partial response (PR) rate of 6.2%. Notably, 82% of responders were estimated to continue to respond to treatment for 9 months or longer. The median time to response was 1.22 months (range, 0.9-6.5), and the median duration of response (DOR) was not yet reached (NR; 95% CI, 12.0-not evaluable [NE]). At a median follow-up of 11.1 months (95% CI, 10.6-12.0), the 6-month and 9-month DOR rates were 90.4% (95% CI, 78.4%-95.9%) and 82.3% (95% CI, 67.1%-90.9%), respectively.