FDA committee recommends approval of Keytruda in high-risk NMIBC
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 9-4 in favour of approving Keytruda for the new indication. The anti-PD-1 therapy has already been approved in the US
The company has unveiled the topline results from its global phase 111 Luster-1 and Luster-2 studies evaluating the efficacy and safety of the investigational oral, once-daily, DP2 receptor