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China Uses New Rules for Fast Approval of Keytruda, a Merck/MSD PD-1 Drug

publication date: Jul 26, 2018

Merck/MSD announced that its PD-1 therapy, Keytruda^®, was approved by the China National Drug Administration for second-line use in patients with metastatic melanoma. It is the first approval of Keytruda in China and the second PD-1 drug to hit China's market. In early June, Opdivo from Bristol-Myers Squibb was approved as a second-line treatment for NSCLC. Keytruda was approved in China under new accelerated approval rules based on a single-arm Phase Ib trial with an endpoint of overall response rate. More details...

Stock Symbols: (NYSE: MRK) (NYSE: BMY)

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