Merck’s Keytruda Receives the NMPA’s Approval as a 2L Treatment for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Merck Receives the US FDA Advisory Committee’s Recommendation on Approval of Keytruda (pembrolizumab) for Patients with High-Risk Non-Muscle Invasive Bladder Cancer


  • 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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