On July 24, 2020, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use recommended granting a conditional marketing authorization in the European Union for belantamab mafodotin, a first-in-class, anti-BCMA immunoconjugate, for the treatment of patients with relapsed and refractory multiple myeloma (RRMM) who are no longer responsive to immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibody treatment. 1
Additionally, on July 14, 2020, the U.S. Food and Drug Administration (FDA) advisory committee voted in favor of the approval of belantamab mafodotin treatment for patients with RRMM who have received ≥ 4 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. 2
The decisions of the EMA and FDA are based on the data from the DREAMM clinical program, particularly the results from the pivotal DREAMM-2 study ( NCT03525678). Click hereto read the latest data from the DREAMM studies presented during the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.