EU Approval Urged for GSX’s Belantamab Mafodotin for Heavily Treated Myeloma

This post was originally published by Myeloma Research News

GlaxoSmithKline’s investigational therapy belantamab mafodotin has been recommended for approved in the European Union, by the Committee for Medicinal Products for Human Use (CHMP), for heavily treated multiple myeloma patients.

The marketing authorization applicationaccepted for review in February, is specific for people with relapsed or refractory disease who were previously treated with an immunomodulatory agent, a proteasome inhibitor, and a CD38-targeting antibody. Of note, refractory cancer, or resistant cancer, does not respond to treatment.

Opinions released by the CHMP, an arm of the European Medicines Agency (EMA), are generally accepted by the European Commission, which makes the final decisions on approving all treatments used in the EU.

“Today’s positive opinion from the CHMP is an important step in helping patients suffering from relapsed or refractory multiple myeloma who currently have limited options and poor outcomes,” Axel Hoos, MD, senior vice president and head of oncology research & development at GSK, said in a press release.

A similar application is currently being analyzed under priority review status by the U.S. Food and Drug Administration (FDA). The agency’s Oncologic Drugs Advisory Committee recently issued a positive recommendation for its approval.

Belantamab mafodotin has received priority medicines status by the EMA and a breakthrough therapy designation by the FDA; both were meant to accelerate its development and review.

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