Belantamab Mafodotin-blmf Combination Approved for Relapsed/Refractory Multiple Myeloma
Expert Perspectives · Lyn Brook · 2025-10-24
The FDA has approved belantamab mafodotin‑blmf (Blenrep, GlaxoSmithKline), a B-cell maturation antigen (BCMA)–directed antibody and microtubule inhibitor conjugate, in combination with bortezomib and dexamethasone (BVd) for adults with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Why This Approval Matters
This approval provides a new BCMA‑targeted triplet regimen for patients with relapsed or refractory multiple myeloma after at least two prior lines, demonstrating substantial improvements in progression‑free and overall survival versus a daratumumab‑based comparator. The regimen offers an immunotherapy‑based option earlier than heavily pretreated settings, addressing a key unmet need.
Breaking Down the DREAMM‑7 Trial
Efficacy was evaluated in DREAMM‑7 (NCT04246047), a phase 3, open‑label, randomized, multicenter study in adults with relapsed or refractory multiple myeloma who had received at least one prior therapy. Patients were excluded if they were refractory or intolerant to daratumumab or bortezomib, received prior BCMA‑directed therapy, and existing corneal disease other than mild punctate keratopathy.
Patients included in the efficacy population (N=217) had received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug (IMiD). Patients were randomized 1:1 to receive:
- Belantamab mafodotin‑blmf, bortezomib, and dexamethasone (BVd) (n=108)
- Daratumumab, bortezomib, and dexamethasone (DVd) (n=109)
Primary efficacy end points included progression‑free survival (PFS) and overall survival (OS). Results favored patients receiving BVd:
- PFS: 31.3 months with BVd vs 10.4 months with DVd
- OS: Not reached vs 35.7 months, respectively
Managing Adverse Events
Ocular toxicity occurred in 92% of patients receiving belantamab mafodotin-blmf in DREAMM-7, including grade 3/4 toxicity in 77% of patients and dosage modification required in 83%. Belantamab mafodotin‑blmf carries a Boxed Warning for ocular toxicity, including corneal epithelium changes that may result in vision deterioration. Because of these risks, belantamab mafodotin‑blmf is available only through the BLENREP REMS program. Additional warnings and precautions include thrombocytopenia and embryo‑fetal toxicity.
Conclusion
“As compared with DVd therapy, BVd therapy conferred a significant benefit with respect to progression-free survival among patients who had relapsed or refractory multiple myeloma after at least one line of therapy,” wrote Vania Hungria, MD, PhD, Co-Founder and Coordinator of the Brazilian Multiple Myeloma Group (GBRAM), and colleagues in their published results of the DREAMM‑7 study.
Dosing and Administration
The dosing recommendation for belantamab mafodotin‑blmf is 2.5 mg/kg IV once every three weeks with bortezomib and dexamethasone for the first eight cycles, then 2.5 mg/kg IV every three weeks as a single agent until disease progression or unacceptable toxicity. Refer to prescribing information for dosing of bortezomib and dexamethasone when used in combination.