^
Association details:
Biomarker:No biomarker
Cancer:Multiple Myeloma
Drug:Elrexfio (elranatamab-bcmm) (CD3 agonist, BCMA inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

Published date:
12/08/2023
Excerpt:
Pfizer Inc...announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO (elranatamab). ELREFXIO is a targeted immunotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies...
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
08/14/2023
Excerpt:
ELREXFIO is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
08/25/2023
Excerpt:
Multiple Myeloma: THERAPY FOR PREVIOUSLY TREATED MULTIPLE MYELOMA...Elranatamab-bcmm…
Evidence Level:
Sensitive: B - Late Trials
Title:

Pfizer’s Elranatamab Receives FDA and EMA Filing Acceptance

Published date:
02/22/2023
Excerpt:
Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company’s Biologics License Application (BLA) for elranatamab, an investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).
Evidence Level:
Sensitive: B - Late Trials
Title:

Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for Relapsed or Refractory Multiple Myeloma

Published date:
11/03/2022
Excerpt:
Pfizer Inc...announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of people with relapsed or refractory multiple myeloma (RRMM)...The Breakthrough Therapy Designation is based on six-month follow-up data from cohort A (n=123) of MagnetisMM-3, an open-label, multicenter, single arm, Phase 2 study evaluating the safety and efficacy of elranatamab monotherapy in patients with RRMM.