China-Only Studies Are ‘Problematic,’ US FDA’s Pazdur Says Ahead Of Lilly/Innovent PD-1 Inhibitor Review
February advisory committee for sintilimab expected to address three main questions about applications relying on single-country data.
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China has fielded several homegrown checkpoint inhibitors, using lower cost as an argument for the US market, but sintilimab – a key test case – has underscored FDA skepticism.
Advisory committee will vote on whether an additional trial demonstrating applicability of results from the Phase III study in China is needed prior to approval; agency says PD-1 inhibitor does not fulfill an unmet need in the US for non-small cell lung cancer.
Ahead of advisory committee, FDA officials raise concerns about the PD-1 inhibitor, which was submitted on the basis of a Phase III trial conducted solely in China. OCE’s Pazdur and Singh make the case for a global, harmonized approach to cancer drug development using multiregional trials.