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Belantamab mafodotin gets positive recommendations from both EMA and FDA to be approved for the treatment of RRMM

Jul 28, 2020

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.

  1. European Medicines Agency. First antibody-drug conjugate for multiple myeloma patients with limited treatment. https://www.ema.europa.eu/en/news/first-antibody-drug-conjugate-multiple-myeloma-patients-limited-treatment-options. Published July 24, 2020. Accessed July 27, 2020.
  2. GSK. GSK announces FDA advisory committee votes in favour of positive benefit/risk profile for belantamab mafodotin for patients with relapsed/refractory multiple myeloma. https://us.gsk.com/en-us/media/press-releases/gsk-announces-fda-advisory-committee-votes-in-favour-of-positive-benefitrisk-profile-for-belantamab-mafodotin-for-patients-with-relapsedrefractory-multiple-myeloma/. Published July 14, 2020. Accessed July 27, 2020.