Blenrep Approved by FDA for Relapsed/Refractory Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted approval for Blenrep (belantamab mafodotin-blmf) as a treatment option for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. This approval addresses a critical need for patients whose cancer has returned or become resistant to standard treatments, offering a new targeted approach to combat the disease.
Multiple myeloma, a cancer of plasma cells, affects thousands of individuals annually. For those experiencing relapse or refractoriness-meaning the cancer returns after treatment or doesn’t respond initially-options are limited.The FDA’s decision, based on data from clinical trials including DREAMM-7 (NCT04246047), provides a perhaps life-extending therapy for this challenging patient population. GSK,the manufacturer of Blenrep,initially received FDA approval for the drug in 2020,which was later voluntarily withdrawn following a required confirmatory trial that did not meet statistical success criteria. This re-approval is based on new data submitted to the FDA.
Blenrep is a B-cell maturation antigen (BCMA)-directed antibody and alkylating agent. It works by targeting BCMA, a protein found on the surface of myeloma cells, and delivering a cytotoxic payload directly to the cancer cells.
The DREAMM-7 trial evaluated Blenrep in combination with bortezomib and dexamethasone against daratumumab, bortezomib, and dexamethasone. further details on the trial can be found on the National Library of Medicine’s website, updated October 24, 2024. GSK announced the FDA approval on October 23, 2025.
