By Fineline Cube 
China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced that the China National Medical Products Administration (NMPA) has approved a new indication for XPOVIO (selinexor). The drug is now approved for use in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy. This marks the third indication for XPOVIO in China.
Drug Profile
XPOVIO is the world’s first approved orally-available, selective XPO1 inhibitor. It has already been approved in ten countries and regions. Previously, the NMPA approved XPOVIO as a monotherapy for patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and in combination with dexamethasone for patients with R/R MM.
Clinical Trial Results
The approval is based on results from the Phase 3 BENCH study. Compared to the Vd regimen (bortezomib and dexamethasone), the XVd regimen demonstrated greater efficacy in Chinese patients with R/R MM who have received at least one prior therapy. Key improvements included longer progression-free survival (PFS), longer duration of response (DOR), higher objective response rate (ORR), and a trend of prolonged overall survival (OS).-Fineline Info & Tech