Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval as a Adjuvant Therapy for Renal Cell Carcinoma

November 19, 2021 Auto Bot approval, FDA, KEYTRUDA, Merck, pembrolizumab, regulatory, Renal Cell Carcinoma 0

Shots:

  • The approval is based on the P-III KEYNOTE-564 trial evaluating Keytruda (200mg, IV, q3w for 1yrs.) vs PBO in a ratio (1:1) in 994 patients with intermediate-high or high risk of recurrence of RCC or M1 NED, following nephrectomy and resection of metastatic lesions
  • The results showed an improvement in DFS, 32% reduction in the risk of disease recurrence or death & the median duration of exposure was 11.1mos.
  • Merck has a broad clinical development program exploring Keytruda, as monothx. or in combination, as well as other investigational products across multiple settings and stages of RCC, including adjuvant and advanced or metastatic disease

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