Keytruda Approved in China for Treatment of Non-Small Cell Lung Cancer

October 14, 2019

China’s National Medical Products Administration approved Merck’s Keytruda (pembrolizumab) as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1.

China granted the approval based on the results of a phase 3 clinical trial that was extended to patients in China, which showed that Keytruda demonstrated a statistically significant improvement in overall survival compared with chemotherapy in patients whose tumors expressed PD-L1.

The approval makes Keytruda the first anti-PD-1 therapy approved in China as both a monotherapy and in combination with chemotherapy for the first-line treatment of patients with NSCLC.

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