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Pharmaceuticals / Submissions and Approvals

Chinese Regulators Approve Keytruda for Lung Cancer

April 9, 2019

Chinese regulators granted Merck’s Keytruda (pembrolizumab) conditional approval in combination with pemetrexed and platinum chemotherapy to treat patients with metastatic nonsquamous non-small cell lung cancer.

China’s National Medical Products Administration says that patients without certain genetic tumor aberrations can take the Keytruda combination.

Keytruda is the first drug to be approved for more than one tumor type in China (it was approved for melanoma in July). The decision comes in the wake of data from a Phase III trial that showed patients in the Keytruda group had better overall and progression-free survival rates.

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