www.fdanews.com/articles/177342-ema-awards-positive-opinion-to-mercks-keytruda
EMA Awards Positive Opinion to Merck’s Keytruda
July 1, 2016
Merck’s Keytruda scored a win with the European Medicines Agency’s Committee for Medicinal Products for Human Use, garnering a positive opinion for treating metastatic non-small cell lung cancer.
The recommendation was based on two clinical studies, which assessed overall survival and overall response rates.
Keytruda is already approved in the EU for the treatment of melanoma, and in the U.S. for the treatment of melanoma and non-small cell lung cancer.