FDA, Adviser Stance On Sintilimab Bodes Ill For Foreign One-Region Trials

By Beth Wang / February 11, 2022 at 4:13 PM
Sending a broader signal to drug makers that products tested in only one region might not pass muster, FDA advisers on Thursday (Feb. 10) overwhelmingly agreed that Eli Lilly and Innovent Biologics need to conduct U.S.-focused trials for their lung cancer drug, sintilimab, falling in line with FDA officials who had raised myriad issues that the drug was only tested in China and not in a U.S. patient population. FDA officials stressed the data are not adequate for U.S. review...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.