Merck Reports the US FDA’s Acceptance of sBLA and Priority Review for Keytruda (pembrolizumab) as an Adjuvant Treatment for RCC

Shots:

• The sBLA is based on P-III KEYNOTE-564 trial evaluating Keytruda monothx. (200mg, IV on day 1 of each 3wks. cycle for ~17 cycles) vs PBO in 994 patients with RCC, following nephrectomy and resection of metastatic lesions
• The results demonstrated an improvement in DFS and were presented at ASCO 2021 with an anticipated PDUFA date as Dec 10, 2021
• Keytruda is currently approved in the US, EU & Japan in combination with axitinib as a 1L treatment for advanced RCC. The company continues to evaluate the therapy in combination or as monothx. across multiple settings & stages of RCC through its broad clinical program including 20 clinical studies & in 4,000+ patients globally

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