For Cancer Drugs With China-Only Data, US FDA Leaves Door Open Just A Crack

Regulatory flexibility may be warranted for diseases with low prevalence in the US, such as nasopharyngeal carcinoma, or for pediatric tumors, which are difficult to study in multi-regional trials, FDA officials said at the advisory committee review of Innovent/Lilly’s lung cancer drug sintilimab; the agency has no plans to change its regulations on evaluation of foreign clinical data.