The China National Drug Administration approved Bristol-Myers Squibb Co.'s Opdivo to treat a certain type of lung cancer.
The Chinese regulator approved Opdivo to treat patients with non-small cell lung cancer, or NSCLC, without EGFR or ALK genomic tumor aberrations, that has locally advanced or has spread in other parts of the body after receiving prior platinum-based chemotherapy.
The approval was backed by the results of the late-stage CheckMate-078 trial in which 90% of the patients were Chinese.
In the trial, Opdivo cut the risk of death by 32% compared to chemotherapy in patients with previously treated NSCLC. The trial was stopped early by the independent data monitoring committee after determining that Opdivo was better than chemotherapy in extending patients' lives.
Bristol said Opdivo is the first and only PD-1 inhibitor as well as immuno-oncology agent approved in China.