EMA approves accelerated process of assessment for GSK 2857916 in relapsed or refractory multiple myeloma.- GlaxoSmithKline

GlaxoSmithKline announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for GSK 2857916 (belantamab mafodotin) for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Belantamab mafodotin was accepted for accelerated assessment by the EMA’s Committee for Human Medicinal Products (CHMP). Accelerated assessment is granted if the CHMP determines the treatment is of major interest from a public health perspective and represents a therapeutic innovation. Validation of the MAA confirms that the submission is accepted and begins the formal review process by the CHMP.The MAA is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study. Full results from the study, recently published in The Lancet Oncology, demonstrated a 31% overall response rate (ORR) with a 2.5 mg/kg regimen of single-agent belantamab mafodotin in heavily pre-treated patients with multiple myeloma who were refractory to an immunomodulatory drug and a proteasome inhibitor and were refractory and/or intolerant to an anti-CD38 antibody. The safety and tolerability profile was consistent with previously reported data on belantamab mafodotin.