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# FDA OKs Pfizer Multiple Myeloma Drug
- URL: https://www.fdaweb.com/fda-oks-pfizer-multiple-myeloma-drug/
- Published: 2023-08-14T12:00:00.000Z
- Updated: 2026-09-14T18:50:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155094

FDA has granted Pfizer accelerated approval for Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager for treating adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Approval was based on data from the MagnetisMM-3 (NCT04649359) study that evaluated the therapy’s objective response rate (ORR) and duration of response (DOR), according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-elranatamab-bcmm-multiple-myeloma?ref=fdaweb.com). “The primary efficacy population consisted of 97 patients naïve to prior BCMA-directed therapy and who had previously received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody,” it says. “The ORR in the 97 patients receiving the recommended dose was 57.7% (95% CI: 47.3%, 67.7%). With a median follow-up of 11.1 months among responders, the median DOR was not reached (95% CI: 12 months, not reached). The DOR rate at 6 months was 90.4% (95% CI: 78.4%, 95.9%) and at 9 months was 82.3% (95% CI: 67.1%, 90.9%).”

The approval also required a Boxed Warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). “Among patients who received elranatamab-bcmm at the recommended dose, CRS occurred in 58% of patients, neurologic toxicity in 59%, and ICANS in 3.3%,” the agency says. “Grade 3 CRS occurred in 0.5% of patients and Grade 3 or 4 neurologic toxicity occurred in 7%.”

Additionally, the agency says it is requiring a Risk Evaluation and Mitigation Strategy restriction due to the risks of CRS and neurologic toxicity, including ICANS.