GlaxoSmithKline plc (LON:GSK) has announced the US Food and Drug Administration Oncologic Drugs Advisory Committee 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.[i] 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. A Marketing Authorisation Application for belantamab mafodotin also is under accelerated assessment by the European Medicines Agency.
Belantamab mafodotin is not currently approved for use anywhere in the world.
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GlaxoSmithKline said: “We are pleased the committee recognised the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options. We look forward to working with the FDA as they complete their review of our Biologics License Application.”