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Elrexfio FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 15, 2023.

FDA Approved: Yes (First approved August 14, 2023)
Brand name: Elrexfio
Generic name: elranatamab-bcmm
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Multiple Myeloma

Elrexfio (elranatamab-bcmm) is a B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) for the treatment of patients with relapsed or refractory multiple myeloma.

Development timeline for Elrexfio

DateArticle
Aug 14, 2023Approval FDA Grants Accelerated Approval for Elrexfio (elranatamab-bcmm) for Relapsed or Refractory Multiple Myeloma
Feb 22, 2023Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance
Dec 10, 2022Pfizer Presents Updated Favorable Elranatamab Data from Pivotal Phase 2 MagnetisMM-3 Trial
Nov  3, 2022Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma
Jun  5, 2022Pfizer Presents First Data from Planned Interim Analysis of Pivotal Phase 2 MagnetisMM-3 Trial of BCMA-CD3 Bispecific Antibody Elranatamab Under Investigation for Relapsed/Refractory Multiple Myeloma
Feb 17, 2021Pfizer Initiates Pivotal Phase 2 MagnetisMM-3 Trial of BCMA-CD3 Bispecific Antibody Elranatamab (PF-06863135) in Multiple Myeloma

Further information

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