GSK has received US Food and Drug Administration (FDA) approval for Blenrep (belantamab mafodotin-blmf) to be used along with bortezomib and dexamethasone for multiple myeloma.
This combination is intended for adults with relapsed or refractory multiple myeloma who have received a minimum of two previous therapies, including an immunomodulatory agent and a proteasome inhibitor.
The approval is based on data from the pivotal DREAMM-7 Phase III trial, which evaluated patients who had received two or more treatments.
Data from the study showed that Blenrep in combination achieved a 51% reduction in risk of death and tripled median progression-free survival to 31.3 months compared to 10.4 months for the daratumumab-based treatment.
Tolerability and safety profiles were consistent with those observed for the individual therapies.
GSK chief scientific officer Tony Wood stated: “Today’s FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients.
“There is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse, and re-treating with the same mechanism of action often leads to suboptimal outcomes.
“We believe Blenrep can redefine treatment for patients with multiple myeloma in all parts of the world, and we are accelerating its development in earlier lines of therapy to support its use across all stages of this difficult-to-treat cancer.”
Blenrep will be supplied via a new, streamlined risk evaluation and mitigation strategy in the US, supporting patient safety, appropriate use and improved administrative efficiency for healthcare professionals and patients.
The company will submit data from the DRiving Excellence in Approaches to Multiple Myeloma (DREAMM) clinical trial programme to the National Comprehensive Cancer Network (NCCN) guidelines in 2025.
In July 2025, GSK secured approval in the European Union for Blenrep combinations to treat adults with relapsed or refractory multiple myeloma.
