FDA Advisory Committee recommends belantamab mafodotin to treat relapsed or refractory multiple myeloma.- GSK

GlaxoSmithKline announced the FDA Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients with relapsed or refractory multiple myeloma 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 programme, 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).