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

Ref: Merck | Image: Merck