FDA committee backs GSK's multiple myeloma drug

GlaxoSmithKline's belantamab mafodotin has been backed for approval to treat relapsed/refractory multiple myeloma by the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC).

The 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.

The decision was based on data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme, including the pivotal DREAMM-2 study, in which the drug demonstrated a 31% overall response rate (ORR) in heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care.

“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,” said Dr Axel Hoos, senior vice president and head of Oncology R&D, GSK. “We look forward to working with the FDA as they complete their review of our Biologics License Application.”

The drug is also currently under review in Europe.