Belantamab mafodotin

Source: Plasma Cell Neoplasms (Including Multiple Myeloma) Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: April 25, 2025 · Captured 2026-09-09.

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Context: Treatment of Relapsed or Refractory Multiple Myeloma / Treatment Options for Relapsed or Refractory Multiple Myeloma / BCMA-targeting antibody-drug conjugates

Belantamab mafodotin is an antibody-drug conjugate composed of an anti-BCMA monoclonal antibody attached to monomethyl auristatin, which inhibits microtubule formation. In 2020, the FDA approved this antibody-drug conjugate for patients with relapsed or refractory myeloma. However, this approval was withdrawn in 2023 based on findings from a prospective randomized trial in 325 patients with relapsed or refractory myeloma, which compared belantamab mafodotin with pomalidomide plus dexamethasone and showed no significant difference in median PFS.[73][Level of evidence B1] Since then, the results of several European clinical trials may revive interest in seeking FDA approval in the United States.

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Evidence (belantamab mafodotin):

A prospective randomized trial (NCT04246047) included 494 patients with relapsed or refractory myeloma. Patients received either belantamab mafodotin plus Vd or DVd.[74,75]

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A prospective randomized trial (NCT04246047) included 494 patients with relapsed or refractory myeloma. Patients received either belantamab mafodotin plus Vd or DVd.[74,75]

With a median follow-up of 28.2 months, the 3-year OS rate was 74% for the belantamab-Vd group and 60% for the DVd group (HR, 0.58; 95% CI, 0.43–0.79; P = .00023).[75][Level of evidence A1]

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A prospective randomized trial (NCT04246047) included 494 patients with relapsed or refractory myeloma. Patients received either belantamab mafodotin plus Vd or DVd.[74,75]

The median PFS was 36.6 months for the belantamab mafodotin-Vd group and 13.4 months for the DVd group (HR, 0.41; 95% CI, 0.31–0.53; P < .001).[74][Level of evidence B1]

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A prospective randomized trial (NCT04246047) included 494 patients with relapsed or refractory myeloma. Patients received either belantamab mafodotin plus Vd or DVd.[74,75]

Belantamab mafodotin is known to cause ocular toxicity (mostly in the cornea) which was noted in 79% of patients who received the drug in this trial. Monthly corneal examinations allowed for dose modification, and 98% of patients regained normal vision from 20/50 or worse.

A prospective randomized trial (NCT04484623) included 302 patients with relapsed or refractory myeloma. Patients received either belantamab mafodotin plus Pd (BPd) or PVd (pomalidomide, bortezomib, and dexamethasone).[76]

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With a median follow-up of 21.8 months, the 1-year PFS rate was 71% for the BPd group and 51% for the PVd group (HR, 0.52; 95% CI, 0.37–0.73; P < .001).[76][Level of evidence B1]

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Belantamab mafodotin is known to cause ocular toxicity (usually in the cornea). Grade 3 or 4 ocular toxicity occurred in 43% of patients who received the drug in this trial (all-grades toxicity occurred in 89% of patients). Monthly corneal examinations allowed for dose modification, and 9% of patients in the BPd group required early treatment discontinuation.

Summary: The use of BCMA-targeted therapy in the second- or third-line of therapy appears better than the usual standard of care. FDA approval may occur after review of these European trials. The use of belantamab mafodotin may affect the subsequent efficacy of other BCMA-directed therapies that have already been approved by the FDA, including the CAR T-cell therapies, cilta-cel and ide-cel, and the bispecific BCMA T-cell enhancers, teclistamab and elranatamab. Clinical trials must establish the correct sequencing of BCMA-directed therapies. In the meantime, belantamab mafodotin has not been approved by the FDA.

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Preserved source evidence · Not medical advice