GSK’s Belantamab Mafodotin Granted Priority Review

January 31, 2020

The FDA granted GlaxoSmithKline’s GSK2857916 (belantamab mafodotin) priority review 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.

The designation was granted based on the results of a phase 2 clinical trial which studied the drug in a heavily pre-treated patient population that did not respond to an immunomodulatory drug and a proteasome inhibitor, and to an anti-CD38 antibody.

The agency granted GSK2857916 a breakthrough therapy designation in 2017.

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