FDA Approves Belantamab Mafodotin-blmf for Relapsed or Refractory Multiple Myeloma
Posted: Thursday, August 6, 2020
On August 5, the U.S. Food and Drug Administration (FDA) approved the antibody drug-conjugate belantamab mafodotin-blmf (Blenrep) for treatment of adults with relapsed or refractory multiple myeloma. Drug eligibility includes patients who have had four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. Earlier in July, an FDA panel voted unanimously in favor of approving belantamab mafodotin for multiple myeloma treatment.
Belantamab mafodotin-blmf is the first anti–B-cell maturation antigen therapy approved anywhere in the world. The recommended dose for belantamab mafodotin-blmf is 2.5 mg/kg as an intravenous (IV) infusion over approximately 30 minutes once every 3 weeks.
The accelerated FDA approval was based on data from the open-label, multicenter DREAMM-2 study. Patients with multiple myeloma were given either 2.5 mg/kg or 3.4 mg/kg of IV belantamab mafodotin-blmf every 3 weeks until disease progression or unacceptable toxicity. Patients with a median of seven prior lines of treatment showed a clinically meaningful overall response rate of 31% (97.5% confidence interval = 21%–43%). In addition, 73% of patients with a response had a response duration over 6 months. Although the median duration of response was not reached, 73% of responders had a duration of response of at least 6 months.
About 20% or more of patients taking belantamab mafodotin-blmf reported adverse events, with 77% of patients in the study experiencing ocular adverse reactions (keratopathy, changes in visual acuity, blurred vision, and dry eyes). About 2% of patients in the 2.5-mg/kg cohort discontinued treatment because of keratopathy. Other common adverse events were pyrexia, infusion-related reactions, fatigue, and nausea.
For prescribing information on belantamab mafodotin-blmf, visit accessdata.fda.gov.
