Ajay Nooka, MD, FACP, on the FDA Accelerated Approval of Elranatamab

By Cecilia Brown - Last Updated: August 21, 2023

Dr. Nooka of the Winship Cancer Institute at Emory University, discusses the recent US Food and Drug Administration (FDA) accelerated approval of elranatamab (ELREXFIO) and what it means for patients with multiple myeloma (MM).

The accelerated approval of the bispecific antibody is for adults with relapsed or refractory MM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The FDA decision is based upon results from the single-arm phase II MagnetisMM-3 trial of elranatamab.

Dr. Nooka, who served as an investigator on the MagnetisMM-3 trial, highlighted how the accelerated approval of elranatamab will shape the treatment landscape for MM.

“Now we have two BCMA-targeting bispecific antibodies that are approved, which are elranatamab and teclistamab,” Dr. Nooka said. “Any time when we have more availability of these agents, that always benefits the patients.”

He explained that it will be key to evaluate the bispecific antibody in tandem with other therapies.

“Ultimately, this drug will not be used as a single agent, it will be used as [part of] combinations for much deeper responses,” Dr. Nooka said, noting that the approval represents a “unique opportunity” for researchers to “evaluate the combinations and how they could benefit the patients in the future.”

He also shared a critical piece of advice for clinicians.

“Giving the drug in the safest possible way is the key,” Dr. Nooka said. “I would urge for people to use the prophylaxis and to understand more about how to minimize the risk of [cytokine release syndrome] and looking at the benefits that people can get by giving the regimen. This is great progress that we have made.”

Elranatamab previously received Breakthrough Therapy Designation from the FDA in November 2022. The FDA granted priority review to the Biologics License Application in February 2023.

Editorial Board