Xian-Janssen Receives SFDA's Approval For Velcade
This article was originally published in PharmAsia News
Executive Summary
Xian-Janssen has obtained approval from China's State FDA for Velcade (bortezomib) for treatment of mantle cell lymphoma, representing China's first drug for the disease. MCL, originating in the lymph nodes, is a lymphoma subtype with poor prognosis and short survival time. In China, its incidence rate ranks 9 and 10 respectively in all male and female malignant tumors. Bortezomib appeared as the world's first targeted protease inhibitor and received approval from U.S. FDA in 2008 for first- and second-line treatment for multiple myeloma and MCL, respectively. According to Phase II clinical trials jointly conducted by 35 clinical centers in the U.S., U.K. and Germany, bortezomib single-agent has shown effectiveness in the treatment of relapsed or refractory MCL. (Click here for more - Chinese language)