On Friday, the U.S. Food and Drug Administration (FDA) approved GSK Plc’s (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy.
The Blenrep approval is supported by data from the pivotal DREAMM-7 phase 3 trial.
Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are more than 180,000 new cases of multiple myeloma diagnosed globally each year.
In 2022, GSK withdrew the U.S. marketing authorization for Blenrep following the FDA request, based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
In patients who had two or more prior lines of therapy, Blenrep in combination demonstrated a clinically meaningful 51% reduction in the risk of death and a tripled median progression-free survival (PFS) of 31.3 months versus 10.4 months for Johnson & Johnson’s (NYSE:JNJ) Darzalex (daratumumab)-based triplet (DVd).
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The safety and tolerability profiles of the Blenrep combination were broadly consistent with the known profiles of individual agents.
Working closely with the FDA, Blenrep is available through a new, streamlined Risk Evaluation and Mitigation Strategy (REMS).
Data from the DREAMM clinical trial program will be submitted to the National Comprehensive Cancer Network guidelines this year.
GSK is advancing the DREAMM clinical program to demonstrate Blenrep’s potential benefit in earlier lines of treatment.
Follow-up continues for overall survival in 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 3 trial in newly diagnosed transplant-ineligible patients, representing over 70% of patients starting therapy, was initiated in the fourth quarter of 2024.
Interim efficacy and safety data for Blenrep as a first-line treatment are expected in early 2028.
In July, the FDA’s Oncologic Drugs Advisory Committee voted against the overall benefit-risk profile of Blenrep combinations at the proposed dosages.
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