This week, Pfizer (NYSE: PFE) received an accelerated approval from the US Food and Drug Administration (FDA) for its bispecific antibody (BsAb) Elrexfio (elranatamab) as a treatment for relapsed or refractory multiple myeloma (r/rMM) in adults who have received at least four prior lines of therapy. The decision was based on Phase II patient response data and is contingent upon evidence of survival or symptoms improvement from confirmatory trials.
Elrexfio’s Mechanism of Action and Dosing
Elrexfio binds CD3 on T cells, directing the lymphocytes towards BCMA expressed on multiple myeloma (MM) cells. This targeted approach offers a new option for patients with r/rMM. The administration frequency can be reduced from once-weekly to once-biweekly for responding patients after an initial phase of 24 weeks, providing flexibility in treatment.
Recent Approvals in the Multiple Myeloma Space
The announcement follows closely on the heels of the accelerated approval in the US of Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen’s GPRC5D/CD3 BsAb Talvey (talquetamab) for a similar r/rMM indication. This highlights the ongoing development and approval of innovative therapies for multiple myeloma, offering hope for patients with limited treatment options.-Fineline Info & Tech
