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DewDiligence

11/09/18 5:24 PM

#222088 RE: DewDiligence #219997

FDA approves Keytruda monotherapy for second-line HCC:

https://finance.yahoo.com/news/fda-approves-merck-keytruda-pembrolizumab-212100345.html

This is an accelerated approval based on ORR (17%) and duration of response in the single-arm KEYNOTE-224 study. Patients were either refractory to, or ineligible for, Sutent, or had Child-Pugh-A cirrhosis. Today is the PDUFA date.