GSK announces MHLW accepted for review a NDA for Blenrep

GSK announced that Japan’s Ministry of Health, Labour and Welfare, MHLW, has accepted for review a new drug application, NDA, for Blenrep in combination with bortezomib plus dexamethasone, BorDex, or pomalidomide plus dexamethasone, PomDex, as a treatment for relapsed or refractory multiple myeloma. MHLW also has granted orphan drug designation for Blenrep, which reflects the high unmet medical need and ensures priority NDA review in multiple myeloma. This is the third major regulatory filing acceptance for belantamab mafodotin combinations in the treatment of relapsed/refractory multiple myeloma. The application is based on interim results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints