FDA re-approves Blenrep combo for relapsed/refractory multiple myeloma, with DREAMM-7 data showing significant survival benefit and reduced mortality risk.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
GSK has announced that China’s National Medical Products Administration has approved Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.
This approval, granted under priority review with Breakthrough Therapy Designation, is based on results from the phase III DREAMM-7 trial, which demonstrated significant improvements in progression-free and overall survival compared to a daratumumab-based regimen, including nearly tripling median progression-free survival and reducing the risk of death by 42%.
Multiple myeloma remains an incurable hematologic malignancy with a high likelihood of relapse, creating an ongoing need for effective and accessible therapies.
Blenrep, an antibody-drug conjugate targeting BCMA, offers a differentiated mechanism of action and is the only approved anti-BCMA ADC.
It can be administered as a 30-minute outpatient infusion, making it a practical option across treatment settings without the need for complex hospital-based procedures.
The combination therapy showed durable and clinically meaningful responses across patient groups, including those with high-risk disease features. Its safety profile was consistent with known effects of the individual agents, with common adverse events including thrombocytopenia and diarrhoea, while ocular toxicity can be managed with monitoring and dose adjustments, resulting in low discontinuation rates.
This approval expands access to advanced targeted therapy in a growing patient population and strengthens the role of BCMA-directed treatments in multiple myeloma, offering a new option for improving disease control and survival outcomes.
The re-approval by the U.S. Food and Drug Administration and positive recommendation from National Institute for Health and Care Excellence (NICE) highlight strong and consistent evidence supporting its efficacy, including a substantial reduction in mortality risk in the DREAMM-7 trial.
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About the Author
Sana Jamil Khan is a B.Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.