GSK reports EMA accepts marketing authoriaation application for Blenrep combos

GSK plc announced that the European Medicines Agency has accepted the marketing authoriaation application, or MAA, for Blenrep, or belantamab mafodotin, in combination with bortezomib plus dexamethasone, or BorDex, or pomalidomide plus dexamethasone, or PomDex, as a treatment for relapsed or refractory multiple myeloma. The EMA’s Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission regarding this potential authorisation. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: “Today’s milestone reinforces the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after first relapse. We are working to bring Blenrep to patients as quickly as possible given the high unmet need and the clinically robust effects of the Blenrep combinations in the DREAMM-7 and DREAMM-8 phase III head-to-head trials.”