Elranatamab receives breakthrough therapy designation for the treatment of RRMM

Elranatamab (PF-06863135), an investigational B-cell maturation antigen CD3-targeted bispecific antibody, has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who have received at least one agent in each of three primary classes of myeloma drugs (i.e., one proteasome inhibitor, one immunomodulatory drug, and one anti-CD38 antibody).¹ Elranatamab received FDA fast-track designation in February 2021.

The Multiple Myeloma Hub has previously summarized data from the phase I MagnetisMM-1 trial. The latest designation is based on results from the phase II, open-label MagnetisMM-3 trial (NCT04649359), a single-arm, multicenter study. Patients in the treatment arm (n = 123) received an elranatamab dose of 76 mg once weekly, with a 2-step-up priming dose during the first week.¹

New data from the MagnetisMM-1 and MagnetisMM-3 trials are expected to be announced at the upcoming 64th American Society of Hematology Annual Meeting and Exposition.^2,3

Elranatamab has also been granted orphan drug designation by the European Medicines Agency (EMA).⁴