STAT+: FDA’s top cancer regulator gives cool reception to drug Lilly licensed from Chinese drugmaker

A Food and Drug Administration meeting scheduled for next week to review a Chinese-developed cancer immunotherapy is likely to be challenging for drug sponsor Eli Lilly, following skeptical comments published Friday evening by the U.S. agency’s top cancer regulator.
Writing in Lancet Oncology , the FDA’s Richard Pazdur described imported cancer drug data from China as a “bridge over troubled waters.” As an example, Pazdur singled out sintilimab, an anti-PD-1 checkpoint inhibitor developed by the China-based drugmaker Innovent and licensed to Lilly. Continue to STAT+ to read the full story…