EMA validates GSK's MAA for myeloma prospect

The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for belantamab mafodotin in relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

Belantamab mafodotin is an anti-BCMA candidate from UK drugmaker GlaxoSmithKline (NYSE: GSK). It was accepted for accelerated assessment by the EMA’s Committee for Human Medicinal Products.

The MAA is based on data from the pivotal DREAMM-2 study, which demonstrated a 31% overall response rate with a 2.5mg/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.