FDA accelerates approval for multiple myeloma immunotherapy

Multiple myeloma

The US Food and Drug Administration (FDA) has granted accelerated approval to Pfizer’s Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM).

The drug is approved in patients 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 the results of the Phase II MagnetisMM-3 trial, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial(s).

Among the patients in the study who received four or more lines of therapy prior to Elrexfio, the overall response rate was 58%, with an estimated 82% maintaining the response for at least nine months.

Elrexfio is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy that binds to BCMA on myeloma cells and CD3 on T-cells, bringing them together and activating the T-cells to kill myeloma cells.

“Most multiple myeloma patients will experience relapse or resistance of their disease to treatment, often facing increased symptom burden and lowering their chance of surviving longer with each attempted line of therapy,” said MagnetisMM clinical trial investigator Ajay Nooka, Director of the Multiple Myeloma Program at Winship Cancer Institute of Emory University.

“By offering durable clinical response with an established safety profile and the convenience of subcutaneous administration, Elrexfio provides a much-needed new option for heavily pre-treated multiple myeloma patients who are struggling with relapsed myeloma.”

Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World

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