GSK plc has announced FDA approval of 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 therapies, including a proteasome inhibitor and an immunomodulatory agent.

The approval is based on data from the phase III DREAMM-7 trial, which showed Blenrep BVd reduced the risk of death by 51% (HR 0.49; 95% CI: 0.32–0.76) and tripled median progression-free survival to 31.3 months versus 10.4 months for a daratumumab-based regimen (DVd) (HR 0.31; 95% CI: 0.21–0.47). Safety profiles were consistent with known data for the individual agents.

“This FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients,” said Tony Wood, Chief Scientific Officer, GSK. “As the only anti-BCMA agent that can be administered across healthcare settings, including in community centers where 70% of patients receive care, Blenrep fulfills a major patient need.”

Blenrep will be distributed under a streamlined Risk Evaluation and Mitigation Strategy (REMS), designed to enhance safety while reducing administrative burden. GSK also launched “Together with GSK,” a support program for patients and providers addressing insurance, cost, and education.

GSK is advancing the DREAMM clinical program to evaluate Blenrep in earlier treatment lines. Phase III trials DREAMM-8 and DREAMM-10 are ongoing, with overall survival data expected in 2028. DREAMM-10 targets newly diagnosed, transplant-ineligible patients—over 70% of the treatment population.

Blenrep combinations are approved in the EU, UK, Japan, Canada, Switzerland, and Brazil. Regulatory reviews are underway in additional markets, including China, where the drug has received Breakthrough Therapy Designation and Priority Review.