Date set for FDA advisory panel review of belantamab mafodotin in MM

The US Food and Drug Administration will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to review data supporting the Biologics License Application (BLA) for belantamab mafodotin submitted by UK pharma major GlaxoSmithKline (LSE: GSK), for the potential treatment of patients with relapsed or refractory multiple myeloma (MM) who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. The ODAC will meet virtually on July 14, 2020.

Dr Axel Hoos, senior vice president and head of oncology R&D, GSK said: “We believe belantamab mafodotin and the results from the DREAMM clinical trial program have significant potential for patients with relapsed/refractory multiple myeloma who have limited treatment options. We look forward to participating in the upcoming advisory committee meeting and working with the FDA to complete its review of the BLA.”

Belantamab mafodotin received Breakthrough Therapy designation in 2017, and the BLA was granted Priority Review status by the FDA in January 2020 based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study. Six-month primary results from the study were published in The Lancet Oncology and follow-up data were presented at the 2020 American Society of Clinical Oncology annual meeting. The marketing authorization application (MAA) for belantamab mafodotin, which was also granted PRIME designation in 2017, was validated by the European Medicines Agency in February this year.