Blenrep (belantamab mafodotin) combination accepted for priority review in China in relapsed/refractory multiple myeloma

CAR-T Digest - August 2020

09 Dec 2024: Blenrep (belantamab mafodotin) combination accepted for priority review in China in relapsed/refractory multiple myeloma

The National Medical Products Administration (NMPA) of China has accepted a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) for relapsed/refractory multiple myeloma, granting it priority review and Breakthrough Therapy Designation
This marks the seventh major regulatory filing acceptance for belantamab mafodotin combinations in 2024, with approvals sought in regions including the US, EU, Japan, UK, Canada, and Switzerland
The phase III DREAMM-7 trial demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS) with the BVd combination compared to standard care (daratumumab, bortezomib, and dexamethasone – DVd)
The DREAMM-7 trial, involving 494 participants, met its primary endpoint of PFS and secondary endpoint of OS, suggesting the BVd regimen’s significant clinical benefit over standard care