Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Stage II Resected High-Risk Melanoma

August 5, 2021 Auto Bot KEYTRUDA, Merck, P-III, pembrolizumab, regulatory 0

Shots:

  • The priority review is based on P-III KEYNOTE-716 trial assessing Keytruda (anti-PD-1 therapy) vs PBO in 954 patients aged ≥12yrs. with stage II resected high-risk melanoma. The anticipated PDUFA date for the therapy is Dec 04, 2021
  • The trial met its 1EPs of RFS with no new safety signals observed. Based on this data, the US FDA has accepted a new sBLA for Keytruda as the adjuvant treatment of adult & pediatric aged≥12yrs. patients with stage IIB or IIC melanoma following complete resection
  • The company has an expansive program to evaluate the therapy in early disease states with ongoing ~20 registrational studies

Click here to­ read full press release/ article | Ref: Merck | Image: Fortune

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