FDA Approves Blenrep for Treatment of Relapsed or Refractory Multiple Myeloma

The FDA has approved belantamab mafodotin-blmf (Blenrep; GSK) in combination with bortezomib and dexamethasone (BVd) for the treatment of relapsed or refractory multiple myeloma among adults who have received at least 2 prior lines of therapy.¹

“Today’s FDA approval of [belantamab mafodotin-blmf] 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,” said Tony Wood, chief scientific officer at GSK, according to a news release.¹

As a monoclonal antibody-drug conjugate (ADC), belantamab mafodotin-blmf includes a humanized B-cell maturation antigen (BCMA) conjugated to the cytotoxic agent auristatin F via a noncleavable linker.¹

How Common Is Multiple Myeloma?

Multiple myeloma is the third most common blood cancer globally, with nearly 180,000 new diagnoses each year. The blood cancer is treatable but not curable, and many cases become nonresponsive or refractory to available treatments within 60 days of the last treatment. Individuals with primary refractory disease fail to respond to initial treatment without evidence of progression.^1,2

Relapsed multiple myeloma is different from being diagnosed with another type of cancer, and individuals are at an increased risk of developing acute myeloid leukemia and myelodysplastic syndrome, both of which are blood cancers.²

"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 [belantamab mafodotin-blmf] in combination to help patients achieve this," Michael Andreini, president and chief executive officer of the Multiple Myeloma Research Foundation and the Multiple Myeloma Research Consortium, said in the news release.¹

Clinical Trial Data Supporting Blenrep Approval

The approval of belantamab mafodotin-blmf is based on data from the multicenter, open-label, randomized phase 3 DREAMM-7 trial (NCT04246047), which evaluated the safety and efficacy of the monoclonal ADC combined with the daratumumab-based triplet (DVd).¹

A total of 494 patients were included and randomly assigned to receive either BVd or DVd with a 2.5-mg/kg intravenous dose of belantamab mafodotin-blmf every 3 weeks in combination for the first 8 cycles, then continued as a single agent.¹

The results of the trial demonstrated a 51% reduction in the risk of death, along with an increased median progression-free survival of 31.3 months among patients who received 3 lines or more of prior therapy.^1,3

“With the approval of [belantamab mafodotin-blmf], we now have a community-accessible BCMA-targeting agent with the potential to improve outcomes for patients following 2 or more prior lines of treatment, where options are limited. This approval marks an important advance in the US relapsed/refractory treatment landscape,” Sagar Lonial, MD, chief medical officer, Winship Cancer Institute of Emory University in Atlanta, Georgia, and chair of Emory Department of Hematology and Medical Oncology, said in the news release.¹

GSK noted that it is advancing the DREAMM program to evaluate belantamab mafodotin-blmf in earlier treatment settings. Ongoing follow-up from the DREAMM-7 and DREAMM-8 (NCT04484623) trials will provide overall survival data in early 2028, including patients with only 1 prior therapy.^1,4

REFERENCES

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

2. Multiple myeloma relapse. City of Hope. Updated June 5, 2023. Accessed October 24, 2025. https://www.cancercenter.com/cancer-types/multiple-myeloma/types/relapsed-multiple-myeloma

3. Evaluation of efficacy and safety of belantamab mafodotin, bortezomib and dexamethasone versus daratumumab, bortezomib and dexamethasone in participants with relapsed/​refractory multiple myeloma (DREAMM 7). ClinicalTrials.gov. Updated October 24, 2024. Accessed October 23, 2025. https://www.clinicaltrials.gov/study/NCT04246047

4. Belantamab mafodotin plus pomalidomide and dexamethasone (Pd) versus bortezomib plus Pd in relapsed/​refractory multiple myeloma (DREAMM 8). ClinicalTrials.gov. Updated March 18, 2025. Accessed October 24, 2025. https://clinicaltrials.gov/study/NCT04484623