EMA validates GSK's MAA for myeloma prospect

3 February 2020
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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.

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