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Home » FDA Cancer Lead Signals Distaste for Sintilimab’s China-Only Data Package
FDA Cancer Lead Signals Distaste for Sintilimab’s China-Only Data Package
FDA’s top cancer specialist is already waving a red flag at sintilimab, saying the Eli Lilly-licensed Chinese oncology drug — scheduled for review by an FDA advisory committee this week — might not be suitable for a U.S. approval based on its single-country pivotal trial data.