Posted by Michael Wonder on 22 Feb 2023
Pfizer’s elranatamab receives FDA and EMA filing acceptance
22 February 2023 - Submissions based on favourable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma.
Pfizer announced today that the US FDA has granted priority review for the company’s biologics license application for elranatamab, an investigational B-cell maturation antigen CD3 targeted bispecific antibody, for the treatment of patients with relapsed or refractory multiple myeloma.
The EMA has also accepted elranatamab’s marketing authorisation application. The company is working closely with the EMA to facilitate their review and will provide updates on timing as appropriate.
