GSK plc announced today that the US Food and Drug Administration (FDA) has approved its cancer therapy Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of treatment, including a proteasome inhibitor and an immunomodulatory agent.
The approval is based on results from the pivotal phase III DREAMM-7 trial, which showed that Blenrep combined with BVd reduced the risk of death by 51% and tripled median progression-free survival to 31.3 months, compared with 10.4 months for a daratumumab-based regimen. The safety profile was consistent with that of the individual treatments.
Tony Wood, Chief Scientific Officer at GSK, said the approval marks a major milestone in improving outcomes for patients with multiple myeloma. “There is an urgent need for new and novel therapies, as nearly all patients experience relapse,” he said. “Blenrep can be administered across healthcare settings, including community centres where most patients receive care, fulfilling a major unmet need.”
The drug will be distributed under a new, simplified Risk Evaluation and Mitigation Strategy (REMS) programme designed to support safe use while easing administrative requirements for healthcare providers. GSK will also provide Together with GSK, a patient support programme for those prescribed Blenrep in the US.
Dr. Sagar Lonial, Chief Medical Officer at the Winship Cancer Institute of Emory University, said the approval offers a “community-accessible BCMA-targeting agent with the potential to improve outcomes where options are limited.”
Michael Andreini, CEO of the Multiple Myeloma Research Foundation, said the decision represents “hope for patients living through cycles of remission and relapse,” providing a chance for longer quality time with loved ones.
GSK continues to advance its DREAMM clinical programme, exploring Blenrep’s use in earlier treatment lines. Ongoing trials, including DREAMM-8 and DREAMM-10, are expected to deliver overall survival and first-line therapy data by early 2028.
The FDA approval positions Blenrep as a key option in the evolving treatment landscape for multiple myeloma, expanding access to an effective BCMA-targeting therapy for US patients.