By Marie Rosenthal
In a 14-to-1 vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) said additional clinical trials with the investigational drug sintilimab (Innovent/Lilly) should be conducted before the agency considers its biologic license application to treat nonsquamous non-small cell lung cancer (nsqNSCLC) in U.S. patients.
At issue was the patient demographics in the ORIENT-11 trial, which was a study conducted in China evaluating the use of sintilimab versus chemotherapy