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

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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