FDA signals progress on the western front for belantamab mafodotin

The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy.

The FDA has assigned the GSK (LSE: GSK) filing a Prescription Drug User Fee Act action date of July 23, 2025.

Hesham Abdullah, senior vice president, global head oncology, R&D, GSK, said: “Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration.