FDA converts Keytruda's tumor-agnostic TMB-high approval to full approval but narrows the cutoff
TMB-high is now defined as at least 13 mutations per megabase, down from 10, after benefit was not confirmed between 10 and 13; response rate was 36%.
TMB-high is now defined as at least 13 mutations per megabase, down from 10, after benefit was not confirmed between 10 and 13; response rate was 36%.