The European Commission approves belantamab mafodotin for the treatment of patients with RRMM

On August 26, 2020, the European Commission granted a conditional marketing authorization to belantamab mafodotin, a first-in-class humanized anti-B-cell maturation antigen (BCMA) monotherapy, for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have previously received at least four therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and experienced disease progression on the last treatment.¹

The approval was based on the results from the DREAMM-2 trial (NCT03525678), which demonstrated that belantamab mafodotin monotherapy, administered as a 2.5 mg/kg dose every 3 weeks, resulted in an overall response rate of 32% in patients with RRMM. In the 13-month follow-up period, the median duration of response was 11 months, and the median overall survival was 13.7 months.

Overall, belantamab mafodotin was safe and tolerable. The most frequently reported adverse events in the 2.5 mg/kg arm were keratopathy (71%), thrombocytopenia (38%), anemia (27%), blurred vision events (25%), nausea (25%), and pyrexia (23%).

Earlier this month, the U.S. Food and Drug Administration (FDA) granted approval to belantamab mafodotin monotherapy in the same setting; click here for the update, which includes the Society for Immunotherapy of Cancer (SITC) recommendations for the use of belantamab mafodotin.

Click here to read the full prescribing information of belantamab mafodotin (for use in the U.S.).