FDA Approval Insights: Elranatamab in Relapsed/Refractory Multiple Myeloma

Welcome to OncLive On Air^®! I’m your host today, Ashling Wahner.

OncLive On Air^® is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive^® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Ajay K. Nooka, MD, MPH, FACP, about the FDA approval of elranatamab-bcmm (Elrexfio) in patients with relapsed/refractory multiple myeloma. Dr Nooka is a professor and the director of the Myeloma Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine, as well as the associate director of clinical research and scientific director of the Winship Data and Technology Applications Shared Resource at Winship Cancer Institute of Emory University in Atlanta, Georgia.

On August 14, 2023, the FDA granted accelerated approval to the bispecific antibody elranatamab for adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior lines of therapy, including an immunomodulatory agent, an anti-CD38 monoclonal antibody, and a proteasome inhibitor. This regulatory decision was supported by findings from the single-arm phase 2 MagnetisMM-3 trial (NCT04649359), in which the agent elicited a 57.7% overall response rate (ORR; 95% CI, 47.3%-67.7%) in the cohort of patients with no prior exposure to BCMA-directed therapy. In the cohort of patients who had received a prior BCMA-directed therapy, the ORR was 33.3% (95% CI, 22.0%-46.3%).

In our exclusive interview, Dr Nooka discussed the significance of this approval, key efficacy and safety data from MagnetisMM-3, and the evolving role of bispecific antibodies in the multiple myeloma treatment paradigm.

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