GSK announces CDE of NMPA in China granted BTD for Blenrep

GSK announced that the Center for Drug Evaluation, CDE, of the National Medical Products Administration, NMPA, in China has granted Breakthrough Therapy Designation, BTD, for Blenrep combined with bortezomib plus dexamethason, BorDex, for the treatment of relapsed or refractory multiple myeloma. NMPA BTD is intended to expedite the development of therapies for serious and life-threatening diseases for which there are no existing treatments or where initial evidence has shown an improvement in patient outcomes over available treatment options. BTD was granted based on the interim results of the phase III head-to-head DREAMM-7 trial, which met its primary endpoint, showing statistically significant and clinically meaningful improvements in progression-free survival for belantamab mafodotin combined with BorDex compared to daratumumab plus BorDex in relapsed or refractory multiple myeloma.