USFDA Approves GSK’s Blenrep for Relapsed/Refractory Multiple Myeloma, Showing Superiority Over Daratumumab-based Regimen

GSK plc has announced that the US Food and Drug Administration (FDA) has granted approval for Blenrep (belantamab mafodotin-blmf). This approval is for Blenrep in combination with bortezomib and dexamethasone (BVd), specifically targeting adult patients with relapsed or refractory multiple myeloma who have undergone at least two prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.

DREAMM-7 Trial Data Underpins Approval

The FDA’s decision is strongly supported by compelling data from the pivotal DREAMM-7 Phase III trial. In patients who had received two or more prior lines of therapy (3L+), including a PI and an IMID, the Blenrep combination demonstrated:

A clinically meaningful 51% reduction in the risk of death [HR 0.49, 95% CI: 0.32-0.76] compared to a daratumumab-based triplet (DVd).
A tripled median progression-free survival (PFS) of 31.3 months [95% CI: 23.5-NR)] for Blenrep + BVd, versus 10.4 months [95% CI: 7.0-13.4] for DVd. This translates to an HR of 0.31 [95% CI: 0.21-0.47] for PFS.

The safety and tolerability profile of the Blenrep combination was consistent with the known profiles of its individual components.

Addressing a Critical Unmet Need

Tony Wood, Chief Scientific Officer at GSK, highlighted the urgent need for new and novel therapies in multiple myeloma, as nearly all patients experience relapse, and re-treating with the same mechanism of action often leads to suboptimal outcomes. He emphasized that Blenrep, as the only anti-BCMA agent that can be administered in diverse healthcare settings (including community centers where 70% of patients receive care), addresses a significant patient need.

Sagar Lonial, MD, Chief Medical Officer at Winship Cancer Institute of Emory University, further reinforced the importance of this approval, noting that Blenrep provides a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients with limited options after two or more prior treatments.

Streamlined Access and Future Development

GSK has collaborated closely with the FDA to implement a new, streamlined Risk Evaluation and Mitigation Strategy (REMS) for Blenrep. This revised REMS aims to support appropriate use and patient safety while reducing administrative burdens through simplified patient forms, removal of duplicative checklists, and efficient communication between healthcare providers (HCPs) and eye care specialists. GSK will also offer “Together with GSK,” an optional patient support program for US patients.

GSK is actively advancing its DREAMM clinical program to explore Blenrep’s potential in earlier lines of treatment.

Overall Survival (OS) Data: Follow-up for OS in DREAMM-7 and DREAMM-8 is ongoing, with data expected in early 2028, including for patients who have received only one prior line of therapy.
DREAMM-10: A Phase III trial in newly diagnosed, transplant-ineligible patients (who 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 also expected in early 2028.

The inclusion of US sites in DREAMM-10 will increase US patient representation in the study population, demonstrating GSK’s continued commitment to working with the FDA for US patients.