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FDA Approves Belantamab Mafodotin-blmf for Adults With Relapsed/Refractory MM
On August 5, 2020, the FDA granted accelerated approval to belantamab mafodotin-blmf (Blenrep; GlaxoSmithKline) for the treatment of adults with relapsed or refractory multiple myeloma (MM) previously given at least 4 therapies (eg, an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory drug).
Belantamab mafodotin-blmf was given orphan drug designation, breakthrough therapy designation, and priority review by the FDA.
This approval was based on data from the open-label, multi-center DREAMM-2 clinical trial, in which patients were given belantamab mafodotin-blmf 2.5 mg/kg or 3.4 mg/kg once every 3 weeks until disease progression or unacceptable toxicity occurred.
The efficacy of belantamab mafodotin-blmf was based on overall response rate (ORR) and duration of response, assessed by an independent review committee in tandem with International Myeloma Working Group uniform response criteria.
In the DREAMM-2 study, patients given the recommended dose of 2.5 mg/kg had an ORR of 31% (97.5% CI, 21%-43%), with 73% of responders having responses lasting ≥6 months.
Based on ocular toxicity risks associated with belantamab mafodotin-blmf, the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).
Adverse events reported in ≥20% of belantamab mafodotin-blmf recipients were keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.—Hina M. Porcelli
Source: US Food and Drug Administration. FDA granted accelerated approval to belantamab mafodotin-blmf for multiple myeloma. Updated August 6, 2020. www.fda.gov/drugs/drug-approvals-and-databases/fda-granted-accelerated-approval-belantamab-mafodotin-blmf-multiple-myeloma. Accessed August 6, 2020.
