GSK plc announced that the U.S. Food and Drug Administration (FDA) has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including both a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.
The approval is supported by data from the pivotal DREAMM-7 Phase III trial, which demonstrated that in patients who had received two or more prior lines of treatment (3L+), the Blenrep combination achieved a clinically meaningful 51% reduction in risk of death [HR 0.49, 95% CI: 0.32–0.76] and tripled median progression-free survival (PFS) to 31.3 months [95% CI: 23.5–NR] compared with 10.4 months [95% CI: 7.0–13.4] for a daratumumab-based triplet (DVd) [HR 0.31, 95% CI: 0.21–0.47]. The safety and tolerability of the Blenrep combination were consistent with the 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 US patients,” said Tony Wood, Chief Scientific Officer, GSK. “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.”
Working in collaboration with the FDA, GSK has launched a new, streamlined Risk Evaluation and Mitigation Strategy (REMS) for Blenrep. The updated REMS simplifies patient management by reducing administrative burden, including simplified patient forms, elimination of redundant checklists, and enhanced communication between healthcare professionals and eye care specialists (optometrists or ophthalmologists). GSK will also provide “Together with GSK,” a patient support program available to all U.S. patients prescribed Blenrep.
GSK plans to submit data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program to the National Comprehensive Cancer Network (NCCN) guidelines this year. The growing evidence base, including recent DREAMM trial results and real-world data, continues to reinforce Blenrep’s therapeutic potential.
“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 Sagar Lonial, MD, Chief Medical Officer, Winship Cancer Institute of Emory University, and Chair of Emory’s Department of Hematology and Medical Oncology. “This approval marks an important advance in the US relapsed/refractory treatment landscape.”
“The reality for most patients with multiple myeloma is a relentless cycle of remission and relapse, as their disease becomes refractory to treatments. Patients urgently need more effective treatment options that can offer more quality time with their loved ones. We see the potential for Blenrep in combination to help patients achieve this,” added Michael Andreini, President and Chief Executive Officer of the Multiple Myeloma Research Foundation and the Multiple Myeloma Research Consortium.
GSK continues to expand its DREAMM clinical program to assess Blenrep’s efficacy in earlier lines of therapy. Follow-up for overall survival (OS) in both DREAMM-7 and DREAMM-8 is ongoing, with data expected in early 2028, including in patients treated after only one prior line of therapy. Additionally, DREAMM-10, a Phase III trial in newly diagnosed, transplant-ineligible patients—who represent over 70% of new multiple myeloma cases—was initiated in Q4 2024. Interim efficacy and safety data are expected in early 2028, with expanded enrollment in U.S. sites to strengthen patient representation and support ongoing collaboration with the FDA to bring new treatment options to American patients.
