BMS scores China's first immuno-oncology approval

The State Drug Administration approved Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY), marking China’s first approval of an immuno-oncology agent, according to the pharma. The anti-PD-1 mAb is indicated to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum-based chemotherapy in adult patients without EGFR or ALK mutations.

The application, which had received Priority Review, included data from the Phase III CheckMate -078 trial in which 90% of enrolled patients were Chinese...