FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma
Regulatory approval: On Aug 14, 2023, the FDA granted accelerated approval to elranatamab-bcmm (Elrexfio), a BCMA-directed CD3 T-cell engager, for adults with relapsed/refractory multiple myeloma after ≥4 prior lines including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Approval was supported by the single-arm MagnetisMM-3 trial. In 97 BCMA-naïve patients at the recommended dose, ORR was 57.7% and median DOR was not reached at 11.1 months’ median follow-up among responders.
FDA accelerated approval: elranatamab-bcmm for relapsed/refractory multiple myeloma
Event type: Regulatory approval (accelerated approval)
Date: 2023-08-14
On August 14, 2023, the FDA granted accelerated approval to elranatamab-bcmm (Elrexfio; Pfizer), a bispecific BCMA-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Supporting evidence
Efficacy was evaluated in MagnetisMM-3 (NCT04649359), an open-label, single-arm, multicenter study enrolling patients with measurable disease per IMWG criteria and refractory to at least one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody. Primary endpoints were ORR and DOR by blinded independent central review.
In the primary efficacy population (n=97) who were BCMA-therapy–naïve, had received ≥4 prior lines, and received the recommended dose, ORR was 57.7% (95% CI, 47.3%–67.7%). With median follow-up 11.1 months among responders, median DOR was not reached (95% CI, 12 months–not reached); DOR rates were 90.4% at 6 months and 82.3% at 9 months.
Safety and access
Labeling includes a Boxed Warning for CRS and neurologic toxicity (including ICANS). At the recommended dose, CRS occurred in 58%, neurologic toxicity in 59%, and ICANS in 3.3%. Elranatamab-bcmm is available only through the ELREXFIO REMS.