Multiple myeloma treatment with bispecific antibody regular approval and hematology oncology research
RegulatoryBusiness Wire

Pfizer Receives FDA Regular Approval for Elrexfio in Multiple Myeloma

Pfizer announces FDA regular approval of Elrexfio (elranatamab-bcmm) for adults with relapsed or refractory multiple myeloma, converting prior accelerated approval.

Pfizer today announced that the FDA has granted regular approval to Elrexfio (elranatamab-bcmm) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. This regular approval converts the prior accelerated approval of Elrexfio and is based on updated data from the MagnetisMM-3 trial showing durable responses. The updated data showed an overall response rate of 61% with a median duration of response of 17.1 months. These results confirm the durable clinical benefit of Elrexfio in heavily pretreated multiple myeloma. Pfizer continues to study Elrexfio in earlier lines of therapy.

Original Source

Business Wire
Share: