GSK’s Blenrep Secures FDA Approval

GSK plc (LON: GSK) announced a significant victory with the US Food and Drug Administration (FDA) approving Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for treating adult patients with relapsed or refractory multiple myeloma.

The approval targets patients who have undergone at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent, potentially opening a substantial new revenue stream for the pharmaceutical giant.

The FDA's decision hinges on compelling data from the pivotal DREAMM-7 phase III trial. The study revealed a clinically meaningful 51% reduction in the risk of death and a tripled median progression-free survival (PFS) of 31.3 months compared to 10.4 months for a daratumumab-based triplet (DVd) in patients having undergone two or more prior lines of therapy (3L+), including a PI and an IMID.

The safety and tolerability profiles were consistent with the known profiles of the individual agents.

Blenrep is said to stand out as the only anti-BCMA therapy accessible in community settings, where approximately 70% of patients receive care.

This broad accessibility, coupled with a new and streamlined Risk Evaluation and Mitigation Strategy (REMS) program, is expected to drive rapid adoption and market penetration.

Tony Wood, Chief Scientific Officer, GSK, stated, “Today's FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients.” Wood's statement reinforces the company's focus on addressing the urgent need for novel therapies, especially given the high relapse rate and suboptimal outcomes associated with re-treating with the same mechanism of action.

GSK is actively pursuing the advancement of Blenrep in earlier lines of treatment through its DREAMM clinical program. Follow-up continues for overall survival (OS) in both DREAMM-7 and DREAMM-8 with data expected in early 2028, including in patients who have received only one prior line of therapy.

DREAMM-10, a phase III trial in newly diagnosed transplant-ineligible patients, which represent over 70% of patients starting therapy, was initiated in Q4-2024.

Interim efficacy and safety data for Blenrep as a first line treatment are expected in early 2028 with enrolment expanded to US sites to increase US patient representation in the study population. GSK continues to work with the FDA for US patients.

Approvals outside of the US for Blenrep combinations are in place for 2L+ relapsed or refractory multiple myeloma in the European Union, UK, Japan, Canada, Switzerland and Brazil.

Applications are currently under review in other markets globally, including China where the application is based on the results of DREAMM-7 and has been granted Breakthrough Therapy Designation and Priority Review.