GSK's Blenrep Combination Application in Multiple Myeloma Accepted for Review by EMA

GSK plc's drug Blenrep (belantamab mafodotin), used in combination therapies, is now under review by the European Medicines Agency (EMA) for multiple myeloma. The EMA's Committee for Medicinal Products for Human Use (CHMP) will evaluate the marketing authorization application (MAA) for Blenrep in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex).<br><br>The application is supported by data from the Phase III DREAMM-7 and DREAMM-8 trials. These studies met their primary endpoints, demonstrating statistically significant improvements in progression-free survival (PFS) for the Blenrep combinations compared to standard-of-care treatments.<br><br>Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D at GSK, stated that this milestone reinforces the potential of Blenrep combinations to improve outcomes for patients with relapsed or refractory multiple myeloma. "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," Abdullah added.<br><br>The DREAMM-7 trial compared belantamab mafodotin with BorDex against daratumumab with BorDex, while DREAMM-8 compared belantamab mafodotin with PomDex against bortezomib with PomDex. Both trials showed positive overall survival (OS) trends, though not statistically significant at the interim analysis. The safety profiles of the combination treatments were consistent with the known profiles of the individual agents.<br><br>Multiple myeloma is the third most common blood cancer globally. While generally treatable, it is not curable. Approximately 180,000 new cases are diagnosed annually worldwide, with around 50,000 in Europe. Research into new therapies is crucial as the disease often becomes refractory to existing treatments.