Belantamab Mafodotin Combos Receive EU, Canadian Approval for R/R Myeloma

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R/R Multiple Myeloma | Image credit:

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The European Commission and Health Canada have approved belantamab mafodotin (Blenrep) in combination with bortezomib (Velcade) and dexamethasone (BVd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy; and in combination with pomalidomide (Pomalyst) and dexamethasone (BPd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy, including lenalidomide (Revlimid).1,2

These regulatory decisions were supported by data from the phase 3 DREAMM-7 trial (NCT04246047), which evaluated BVd, and the phase 3 DREAMM-8 trial (NCT04484623), which examined BPd. In both studies, the belantamab mafodotin–based combinations demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) vs standard-of-care triplet regimens.

“With the approval of [belantamab mafodotin] combinations in the European Union, we now have additional tools in our efforts to keep patients in remission longer, maintain quality of life and extend survival,” María-Victoria Mateos, MD, PhD, head of Myeloma and Clinical Trials Unit in the Haematology Department and professor of medicine at the University of Salamanca in Spain, as well as the DREAMM-7 principal investigator, stated in a news release.1

Notably, both of these regulatory approvals followed a July 17, 2025, vote by the FDA’s Oncologic Drugs Advisory Committee (ODAC), which did not endorse the risk:benefit profiles of the proposed dosages of belantamab mafodotin in these combinations.3 Specifically, the ODAC voted 5 to 3 against the risk:benefit profile of the BVd combination and 7 to 1 against the BPd combination. On July 23, GSK announced that the FDA extended the review period for the biologics license application seeking the approval of these combinations; the new Prescription Drug User Fee Act action date is October 23, 2025.4

DREAMM-7 Data

In DREAMM-7, BVd produced a median PFS of 36.6 months compared with 13.4 months for daratumumab (Darzalex) plus bortezomib and dexamethasone (DVd; HR, 0.41; 95% CI, 0.31-0.53; P < .00001).1 The trial also met its key secondary end point, demonstrating a 42% reduction in the risk of death (HR, 0.58; 95% CI, 0.43-0.79; P = .00023) at a median follow-up of 39.4 months. The median overall survival (OS) was not reached (NR) in either arm, although the 3-year OS rate favored the belantamab mafodotin arm (74% vs 60%).

DREAMM-8 Findings

In DREAMM-8, BPd produced a median PFS that was NR (95% CI, 20.6-NR) vs 12.7 months (95% CI, 9.1-18.5) for bortezomib plus pomalidomide and dexamethasone (PVd) at a median follow-up of 21.8 months.

Safety Data

Safety findings from both trials demonstrated that the ocular adverse effects (AEs) commonly associated with belantamab mafodotin were generally manageable and reversible with appropriate dose modifications and routine ophthalmologic monitoring. These measures enabled patients to continue treatment and maintain clinical benefit, with eye-related toxicities leading to treatment discontinuation in less than 9% of patients in both studies.

Non-ocular AEs occurring in more than 30% of patients in the belantamab mafodotin combination arms included thrombocytopenia (87%) and diarrhea (32%) in DREAMM-7, and neutropenia (63%), thrombocytopenia (55%), and COVID-19 (37%) in DREAMM-8. These safety profiles were consistent with the known effects of the individual agents used in combination.

“The robust efficacy supported by the DREAMM-7 and DREAMM-8 trials, together with manageable outpatient administration in academic and community settings, positions [belantamab mafodotin] combinations as a fundamentally differentiated treatment approach for [patients with] multiple myeloma starting from first relapse,” Mateos concluded.

References

  1. Blenrep (belantamab mafodotin) combinations approved in EU for treatment of relapsed/refractory multiple myeloma. News Release. GSK. July 24, 2025. Accessed July 24, 2025. https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-eu-for-treatment-of-relapsedrefractory-multiple-myeloma/
  2. Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma. News Release. GSK. July 23, 2025. Accessed July 24, 2025.https://ca.gsk.com/en-ca/media/press-releases/blenrep-belantamab-mafodotin-combinations-approved-in-canada-for-the-treatment-of-relapsedrefractory-multiple-myeloma/
  3. July 17, 2025, Meeting of the Oncologic Drugs Advisory Committee (ODAC). FDA. Accessed July 24, 2025. https://www.youtube.com/live/CLhBI3UXWyg
  4. GSK announces extension of US Food and Drug Administration review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma. News release. GSK. July 23, 2025. Accessed July 24, 2025. https://www.gsk.com/en-gb/media/press-releases/gsk-announces-extension-of-us-food-and-drug-administration-review-period-for-blenrep-belantamab-mafodotin-blmf-in-relapsedrefractory-multiple-myeloma/

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