FDA Grants Belantamab Mafodotin Priority Review for Myeloma

The FDA granted priority review to the biologics license application of belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma (MM) who were previously treated with an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

Belantamab mafodotin is an anti–B-cell maturation antigen (BCMA) antibody drug conjugate. Its application is supported by data from the phase II DREAMM-2 trial, which enrolled adults with heavily pretreated MM. Patients received belantamab mafodotin at a dose of either 2.5 mg/kg or 3.4 mg/kg. Overall response rates were 31% in the lower-dose cohort and 34% in the higher-dose cohort. The most common grade 3-4 adverse events (AEs) included keratopathy, thrombocytopenia, and anemia. Two patient deaths were reported and considered potentially related to study treatment (1 case of sepsis in the 2.5 mg/kg cohort and 1 case of hemophagocytic lymphohistiocytosis in the 3.4 mg/kg cohort).

Belantamab mafodotin also received breakthrough therapy designation in 2017.

Source: GlaxoSmithKline press release, January 21, 2020.