The designation, for the PD-1 inhibitor toripalimab in nasopharyngeal carcinoma, makes the Shanghai-based company the latest of several Chinese biotech firms to make headway in the U.S. market.
The FDA approved Keytruda as a single agent for patients with first-line metastatic or unresectable colorectal cancer that carries the biomarker MSI-H or dMMR. The drug was the first to win a biomarker-based, tumor-agnostic label, in 2017.
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