FDA has granted priority review to Pfizer’s (NYSE:PFE) bispecific antibody elranatamab for patients with relapsed or refractory multiple myeloma (RRMM).
Also known as PF-06863135, the immunotherapy won breakthrough therapy designation from the FDA for RRMM in November 2022.
The FDA has also accepted elranatamab’s Biologics License Application (BLA) while the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA).
Pfizer anticipates that it will commercialize elranatamab later this year.
The company estimates that elranatamab could generate $4 billion in peak sales. Pfizer anticipates that the drug candidate could capture between 40% and 80% of market share.
Elranatamab targets B-cell maturation antigen (BCMA) on the myeloma cell while binding to the CD3 protein present on the surface of T-cells. The drug candidate can thus unite myeloma cells and T-cells. That action activates the T-cells, ena…