Blenrep Receives FDA Approval for Treatment of Relapsed or Refractory Multiple Myeloma

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The FDA has approved belantamab mafodotin-blmf (Blenrep; GSK) in combination with bortezomib and dexamethasone (BVd) for the treatment of relapsed or refractory multiple myeloma among adults who have received at least 2 prior lines of therapy.¹

“Today’s FDA approval of [belantamab mafodotin-blmf] is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients. There is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse, and re-treating with the same mechanism of action often leads to suboptimal outcomes,” Tony Wood, chief scientific officer, GSK, said in a news release.¹

As a monoclonal antibody-drug conjugate, belantamab mafodotin-blmf includes a humanized B-cell maturation antigen (BCMA) conjugated to the cytotoxic agent auristatin F via a non-cleavable linker.¹

“As the only anti-BCMA agent that can be administered across healthcare settings, including in community centers where 70% of patients receive care, [belantamab mafodotin-blmf] fulfils a major patient need,” Wood said in the news release.¹

The approval of belantamab mafodotin-blmf is based on data from the multicenter, open-label, randomized phase 3 DREAMM-7, which evaluated the safety and efficacy of the monoclonal ADC combined with DVd. The results of the trial demonstrated a 51% reduction in the risk of death, along with an increased median progression-free survival among patients who received 3 lines or more of prior therapy.^1,2

“With the approval of [belantamab mafodotin-blmf], we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following two or more prior lines of treatment, where options are limited. This approval marks an important advance in the US relapsed/refractory treatment landscape,” Sagar Lonial, MD, chief medical officer, Winship Cancer Institute of Emory University in Atlanta, Georgia, and chair of Emory Department of Hematology and Medical Oncology, said in the news release.¹

REFERENCES

1. Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma. News release. GSK. October 23, 2025. Accessed October 23, 2025. https://www.gsk.com/en-gb/media/press-releases/blenrep-approved-by-us-fda-for-use-in-treatment-of-relapsedrefractory-multiple-myeloma/

2. Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/​Refractory Multiple Myeloma (DREAMM 7). National Library of Medicine. Updated October 24, 2024. Accessed October 23, 2025. https://www.clinicaltrials.gov/study/NCT04246047