Keytruda wins eighth FDA approval of 2021, moving into adjuvant and pediatric melanoma settings

Keytruda made history seven years ago as the first anti-PD-1 therapy approved in the US, winning an OK in metastatic melanoma. The drug has since become a megablockbuster, and on Friday earned a new approval in the field that got everything started.

The FDA rubber-stamped Keytruda’s use as an adjuvant, Merck announced, for multiple stages of melanoma in patients older than 12 following complete resection. Previously, Keytruda was approved in the adjuvant setting for adults with Stage III melanoma, but now can be used in adults and adolescents with Stage IIB, Stage IIC and Stage III melanoma as an adjuvant.