Blenrep (belantamab mafodotin) in combination receives Breakthrough Therapy ... - GSK
GSK's Blenrep receives Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma treatment based on DREAMM-7 trial results, showing significant PFS improvements over standard care.
Related Clinical Trials
Reference News
GSK's Blenrep granted Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma treatment, based on DREAMM-7 trial results.
GSK granted breakthrough therapy designation in China for Blenrep, a treatment for relapsed or refractory multiple myeloma, based on DREAMM-7 trial results.
Japan's MHLW accepts GSK's NDA for Blenrep plus BorDex or PomDex for relapsed/refractory multiple myeloma, based on DREAMM-7 and DREAMM-8 trials. Blenrep shows potential to redefine treatment landscape.
CDE of China’s NMPA grants BTD for belantamab mafodotin-blmf plus Vd in relapsed/refractory multiple myeloma, based on DREAMM-7 trial data showing 36.6-month median PFS vs 13.4 months with DVd.
GSK's Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) received Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma. The designation is based on the DREAMM-7 trial's interim results showing significant improvements in progression-free survival (PFS) compared to daratumumab plus BorDex. A positive overall survival (OS) trend was observed but not statistically significant at the interim analysis. The trial also showed deeper and more durable responses across secondary endpoints. Multiple myeloma is a growing concern in China with approximately 30,000 new cases annually.
Japan’s Ministry of Health, Labour, and Welfare accepted an NDA for belantamab mafodotin (Blenrep) plus bortezomib and dexamethasone or pomalidomide and dexamethasone in relapsed or refractory multiple myeloma, supported by phase 3 DREAMM-7 and DREAMM-8 studies showing progression-free survival benefits. A trend toward overall survival was observed, though not statistically significant. A Japan expansion cohort will further examine these protocols.
Japan's health ministry accepts GSK's Blenrep NDA for blood cancer treatment, following EU and UK approvals. Blenrep granted orphan drug status in Japan, supported by DREAMM-7 and DREAMM-8 trials. GSK aims to expedite global regulatory pathways for Blenrep.
GSK's Blenrep receives Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma treatment based on DREAMM-7 trial results, showing significant PFS improvements over standard care.