An office of the U.S. Food and Drug Administration (FDA has recommended that belantamab mafodotin, GlaxoSmithKline’s investigational antibody-drug conjugate, be approved for heavily pretreated relapsed or refractory multiple myeloma patients.
The recommendation by the FDA’s Oncologic Drugs Advisory Committee is for patients who had at least four prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
If approved, belantamab mafodotin will be the first therapy of its class available for advanced multiple myeloma.
“We are pleased the committee recognized 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,” Axel Hoos, senior vice president and head of Oncology Research and Development at GlaxoSmithKline (GSK), said in a press release.
Members of the committee participated in a virtual meeting on July 14 to review and discuss data supporting the investigational treatment’s application.