European Medicines Agency Greenlights Review Of Blenrep Combinations For Myeloma

GSK plc announced today that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin) combined with either bortezomib and dexamethasone (BorDex) or pomalidomide and dexamethasone (PomDex) for the treatment of relapsed or refractory multiple myeloma. The EMA’s Committee for Medicinal Products for Human Use (CHMP) will now commence the formal review process to provide a recommendation to the European Commission for potential approval.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said in a statement, “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.”

The interim findings from the DREAMM-7 and DREAMM-8 phase III trials form the basis of this application. Both trials achieved their primary goals, demonstrating statistically significant and clinically meaningful enhancements in progression-free survival (PFS) when using belantamab mafodotin combinations, compared to standard care regimens in patients with relapsed or refractory multiple myeloma. Specifically, DREAMM-7 is comparing belantamab mafodotin plus BorDex against daratumumab plus BorDex, while DREAMM-8 is assessing belantamab mafodotin with PomDex versus bortezomib plus PomDex.

Although a positive trend in overall survival (OS) was noted in both trials, it did not reach statistical significance at the interim analysis stage. OS follow-up is ongoing. Furthermore, the results indicated clinically meaningful improvements across all secondary efficacy measures, including deeper and more sustained responses relative to the standard care combinations. The safety and tolerability profiles of the belantamab mafodotin combinations in these trials were generally consistent with the established profiles of the individual agents.