FDA grants priority review to belantamab mafodotin for relapsed, refractory multiple myeloma
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The FDA granted priority review to belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma who previously received an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, according to a press release from the drug’s manufacturer.
Belantamab mafodotin (GSK2857916, GlaxoSmithKline) is an investigational anti-B-cell maturation antigen (BCMA) monoclonal antibody-drug conjugate.
The FDA based its decision, in part, on data from the DREAMM-2 study, published in The Lancet Oncology. As Healio previously reported, results of the trial showed belantamab mafodotin induced clinically meaningful response rates among 196 patients with heavily pretreated multiple myeloma.
Researchers randomly assigned 97 patients to a 2.5 mg/kg dose and 99 patients to a 3.4 mg/kg dose. Results showed an overall response rate of 31% (95% CI, 20.8-42.6) in the 2.5 mg/kg group compared with 34% (95% CI, 23.9-46) in the 3.4 mg/kg group. These included very good partial responses or better among 19% (n = 18) of patients in the lower-dose group and 20% (n = 20) of patients in the higher-dose group.
Clinical benefit, defined as minimal response or better as assessed by independent committee review, had been achieved by 34% (95% CI, 24.7-44.3) of patients in the 2.5 mg/kg group and 39% (95% CI, 29.7-49.7) of those in the 3.4 mg/kg group.
Common grade 3 or grade 4 adverse events among safety-evaluable patients in the 2.5 mg/kg and 3.4 mg/kg groups included keratopathy (27% vs. 21%), thrombocytopenia (20% vs. 33%) and anemia (20% vs. 25%).
The FDA, which previously granted this application breakthrough therapy designation, is expected to make a decision regarding approval within the first half of 2020.
Reference:
Lonial S, et al. Lancet Oncol. 2019;doi:10.1016/S1470-2045(19)30788-0.