Shots:

• The approval is based on the P-III (KEYNOTE-564) trial to evaluate Keytruda as monothx. vs PBO in a ratio (1:1) in 994 patients with RCC who are at high risk of recurrence following nephrectomy & resection of metastatic lesions
• In a pre-specified interim analysis, the therapy showed an improvement in DFS, 32% reduction in risk of disease recurrence or death, median follow-up of 23.9mos. while an efficacy results with a median follow-up of 29.7mos. showed 37% reduction in risk of disease recurrence or death, m-DFS has not been reached & continue to evaluate OS
• The approval allows marketing of Keytruda monothx. in all 27 EU member states, Iceland, Lichtenstein, Norway & Northern Ireland

Ref: Businesswire | Image: Merck