FDA panel OKs GSK's multiple myeloma drug

July 14, 2020

The U.S. Food and Drug Administration Oncologic Drugs Advisory Committee voted in favor of GlaxoSmithKline's multiple myeloma treatment.

The committee ruled 12-0 in favor of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients with relapsed or refractory multiple myeloma, a common form of blood cancer, who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Two committee members could not participate in the final vote.

The recommendation was based on data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program, including the pivotal DREAMM-2 study which enrolled heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care. The six-month primary results from the study were published in The Lancet Oncology in December 2019 and serve as the basis for the Biologics License Application (BLA).

The FDA will consider the recommendation of the committee but is not obligated to follow it. The FDA granted breakthrough therapy designation to belantamab mafodotin in 2017 and priority review designation for the BLA earlier this year.

Belantamab mafodotin is not currently approved for use anywhere in the world.

Read the GSK release