Second esophageal cancer indication for Keytruda in China

7 September 2021

Blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) has been approved by China’s National Medical Products Administration (NMPA) in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or gastroesophageal junction (GEJ), US pharma giant Merck & Co (NYSE: MRK) announced today.

This new indication was granted approval based on overall survival (OS) findings from the pivotal Phase III KEYNOTE-590 trial. Keytruda is now approved for eight indications across five different types of cancer in China.

This is the second indication for Keytruda in esophageal cancer in China. In addition to this new approval, Keytruda is cleared in China for a second-line treatment of certain patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10)

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