GSK announced FDA’s approval of Blenrep in combination with bortezomib and dexamethasone (BVd) for the treatment of adults diagnosed with relapsed or refractory multiple myeloma who received a minimum of two previous lines of therapy, such as a proteasome inhibitor (PI) or a immunomodulatory (IMID) agent.¹

“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.

"As the only anti-BCMA agent that can be administered across healthcare settings, including in community centres where 70% of patients receive care, Blenrep fulfils a major patient need. 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,” said Tony Wood, chief scientific officer at GSK.

Why did The FDA approve Blenrep?

FDA’s approval of Blenrep in combination with bortezomib and dexamethasone is backed by data collected from the pivotal DREAMM-7 phase III trial.¹ The trial demonstrated that patients who had two or more prior lines of therapy, including a PI and an IMID, and received Blenrep in combination demonstrated a clinically meaningful 51% reduction risk of death.¹

Results also showed that these patients also tripled median progression-free survival to 31.3 months, compared to 10.4 months for a daratumumab-based triplet.¹ Blenrep’s safety and tolerability profiles remained consistent with the previously established profiles of the combination.¹

Data from the DREAMM-7 phase III trial is expected to be submitted to the National Comprehensive Cancer Network (NCCN) guidelines later this year, as recent trial results, alongside emerging real-world evidence, helps provide a growing body of data for Blenrep’s approval.¹

Sagar Lonial, MD, chief medical officer at the Winship Cancer Institute of Emory University Atlanta, Georgia, and chair of Emory Department of Hematology and Medical Oncology, touched on Blenrep’s approval, saying, “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. This approval marks an important advance in the US relapsed/refractory treatment landscape.”

What is Blenrep’s availability?

According to a press release from GSK, the company is working closely with FDA to make Blenrep available through a new Risk Evaluation and Mitigation Strategy (REMS).¹

GSK’s new REMS is aimed at supporting appropriate use and patient safety, while also reducing administrative burden through simplified patient forms, the removal of duplicative checklists, and enhanced communication between health care providers and either optometrists or ophthalmologists monitoring eye care.¹

Additionally, the company will offer Together with GSK, which is an optional patient support program available to all US patients prescribed Blenrep.¹

Sources

1. Blenrep approved by US FDA for use in treatment of relapsed/refractory multiple myeloma GSK October 23, 2025https://www.gsk.com/en-gb/media/press-releases/blenrep-approved-by-us-fda-for-use-in-treatment-of-relapsedrefractory-multiple-myeloma/