
The investigational cancer immunotherapy drug elranatamab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for relapsed or refractory multiple myeloma (MM).
Elranatamab is a B-cell maturation antigen CD3-targeted bispecific antibody. The decision is based on updated data from the phase II MagnetisMM-3 study that showed an overall response rate of 61% and a manageable safety profile after a median follow-up of 6.8 months. Patients in the MagnetisMM-3 study received elranatamab 76 mg weekly with a two-step-up priming dose regimen used during the first week.
MagnetisMM-3 is part of the MagnetisMM clinical research program, which has “registration-intent trials planned or ongoing that explore elranatamab both as monotherapy and in combination with standard or novel therapies, spanning multiple patient populations from newly diagnosed MM, double-class exposed disease and [relapsed or refractory] MM,” officials said in a news release.
Elranatamab has also been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA) for the treatment of MM. The FDA and EMA have granted elranatamab Fast Track Designation and the PRIME scheme, respectively, for the treatment of patients with relapsed or refractory MM. The Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. has also granted elranatamab the Innovative Medicine Designation and the Innovation Passport for the treatment of MM.
Source: Business Wire, November 2022