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.
The Innovent/Lilly clinical trial “raises questions regarding the data from a single foreign country to support U.S. approval and its generalisability to the American population,” Pazdur wrote, in part because such data “do not fulfill an unmet medical need” in the U.S.
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