China's State Drug Administration approved Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY), marking the country'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.
BMS spokesperson Priyanka Shah said the company expects Opdivo to be available next half. BMS is preparing to submit pricing material to the relevant authorities.
In April, the China State Council said all cancer drugs would be exempt from import tariffs and would be incorporated into China's National Reimbursement Drug List. Manufacturers may have to agree to steep discounts to get their drugs onto the Chinese market as a result.
Shah said the pharma was "working with the government and other stakeholders on possible public health programs" to provide access to the drug but did not go into detail.
At least three other NDAs for anti-PD-1 mAbs are under Priority Review in China: sintilimab (IBI308) from Innovent Biologics Inc. (Suzhou, China); camrelizumab (SHR-1210) from Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:3600276); and according to media outlets, Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK).
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