Pfizer's Elrexfio enters RRMM market with accelerated approval

The US Food and Drug Administration (FDA) has granted accelerated approval to Elrexfio (elranatamab-bcmm).

Pfizer’s (NYSE: PFE) drug has won approval for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) 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 single-arm Phase II MagnetisMM-3 trial, and continued approval for this indication is contingent upon verification of clinical benefit in a confirmatory trial.