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

August 10, 2021 Auto Bot FDA, KEYTRUDA, Merck, pembrolizumab, Priority Review, regulatory, sBLA 0

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

Click here to­ read full press release/ article | Ref: Businesswire | Image: Spagnola & Associates

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