PHILADELPHIA, PA — GSK plc (LSE/NYSE: GSK) announced that the U.S. Food and Drug Administration has approved 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 approval is based on data from the pivotal DREAMM-7 phase III trial, which demonstrated a 51% reduction in the risk of death and a tripling of median progression-free survival—31.3 months compared with 10.4 months for a daratumumab-based triplet regimen. Safety and tolerability were consistent with previously known profiles of the individual agents.
“Today’s FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to U.S. patients,” said Tony Wood, Chief Scientific Officer at GSK. “As the only anti-BCMA agent that can be administered across healthcare settings—including community centers where 70% of patients receive care—Blenrep fulfills a major patient need.”
Blenrep is now the only anti-BCMA therapy available in the community setting, where most patients are treated, and will be distributed under a newly streamlined Risk Evaluation and Mitigation Strategy (REMS) program to simplify administration and reduce the paperwork burden for healthcare providers.
The DREAMM (Driving Excellence in Approaches to Multiple Myeloma) clinical program continues to expand Blenrep’s use into earlier stages of disease. Ongoing studies—including DREAMM-8 and DREAMM-10—are exploring its potential for newly diagnosed and transplant-ineligible patients, with results expected beginning in 2028.
“With the approval of Blenrep, we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following two or more prior lines of treatment, where options are limited,” said Dr. Sagar Lonial, Chief Medical Officer of the Winship Cancer Institute at Emory University.
GSK’s latest oncology milestone underscores its continued commitment to addressing significant unmet needs in hematologic cancers, with Blenrep positioned to redefine treatment for patients living with multiple myeloma.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.