GSK plc announced that the U.S. Food and Drug Administration has approved Blenrep (belantamab mafodotin-blmf) when used along with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have already had at least two previous treatments, including a proteasome inhibitor and an immunomodulatory drug. This approval is based on the results of the pivotal DREAMM-7 phase III trial, which showed that using Blenrep in combination reduced the risk of death by 51% and more than tripled the median progression-free survival to 31.3 months, compared to 10.4 months for a daratumumab-based treatment. The combination was found to be safe and manageable, similar to the individual drugs used.
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Tony Wood, Chief Scientific Officer at GSK, said that the FDA approval is a major milestone that could offer U.S. patients a treatment with better overall survival. He stressed the importance of new treatments, noting that most multiple myeloma patients eventually relapse and often face poor outcomes when retreated with the same therapy. As the only anti-BCMA therapy available in various healthcare settings, including community centers where 70% of patients are treated, Blenrep meets a pressing need. He added that GSK is currently looking into using Blenrep earlier in treatment to help more patients with this challenging disease.
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Blenrep is now available through a new streamlined Risk Evaluation and Mitigation Strategy meant to support safe use and patient care while making the process simpler. The REMS program makes patient forms easier, removes repetitive checklists, and helps communication between healthcare providers and eye specialists. GSK also offers the Together with GSK program, which assists U.S. patients prescribed Blenrep with insurance issues, cost concerns, and ongoing education.
Sagar Lonial, MD, Chief Medical Officer at Winship Cancer Institute of Emory University and Chair of the Emory Department of Hematology and Medical Oncology, said the approval gives patients a community-accessible BCMA-targeting treatment that could improve results after two or more prior treatments, when options are limited. Michael Andreini, CEO of the Multiple Myeloma Research Foundation, added that patients need more effective therapies to have more quality time with loved ones, and that Blenrep has the potential to meet that need.
GSK is continuing the DREAMM clinical program to study Blenrep in earlier treatment stages. Overall survival follow-up from DREAMM-7 and DREAMM-8 is expected in early 2028, including in patients who have had only one prior treatment. The DREAMM-10 phase III trial in newly diagnosed, transplant-ineligible patients started in the fourth quarter of 2024, with initial efficacy and safety data expected in early 2028. Blenrep combinations are also approved for multiple myeloma in the European Union, UK, Japan, Canada, Switzerland, and Brazil, with regulatory applications being reviewed in other markets, including China, where the therapy has Breakthrough Therapy Designation and Priority Review. Multiple myeloma is the third most common blood cancer globally, and although it is generally treatable, it is not curable. With over 180,000 new cases diagnosed each year worldwide, new, effective therapies that can be safely delivered in community settings are urgently needed.
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