Shots:

• The approval is based on P-III KEYNOTE-181 study assessing Keytruda vs CT in previously treated patients with recurrent or metastatic ESCC whose tumors expressed PD-L1 (CPS ≥10) and  data from an extension of the global study in Chinese patients
• Results: Median OS (10.3 vs 6.7mos.)- in Chinese patients: median OS (12.0 vs 5.4mos.). With the approval- Keytruda is now approved for five indications across three different types of cancer in China- including 1L treatment for patients with advanced NSCLC (monothx. and in combination with CT) and as a 2L treatment for advanced melanoma
• Keytruda is an anti-PD-1 therapy- acts by increasing the ability of the body’s immune system to help detect and fight tumor cells. In Jul’2019- the US FDA has approved the therapy for the same indication based on global KEYNOTE-181 study

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Ref: BusinessWire | Image: Merck