The China Drug Administration approved Bristol-Myers Opdivo as a 2nd line treatment for patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC).

China’s health authority recently approved () the first PD-1/L1 checkpoint inhibitor by Bristol-Myers. Its drug, Opdivo (nivolumab), received approval from the China Drug Administration for the 2nd line treatment of patients with locally advanced or metastatic NSCLC. 

Bristol-Myers earned the approval following completion of a Phase 3 study conducted largely with Chinese patients. The study was completed late in 2017, and the Chinese agency responded rapidly, granting accelerated approval for Opdiva in just six months under the priority review pathway. In its announcement of the approval, the agency noted that for patients with advanced cases, Opdiva extended overall survival by “around three months”.  

Merck has filed for approval of its checkpoint inhibitor in February 2018.