Negative FDA AdCom vote for Lilly and Innovent's sintilimab

On Thursday, the Oncology Drug Advisory Committee (ODAC), an advisory panel of the US Food and Drug Administration, voted 14 to 1 that Eli Lilly (NYSE; LLY) and Innovent Biologics (HKEX: 01801) should conduct more trials of their anti-PD-1 antibody sintilimab in order to win approval for the drug in the USA.

The vote come a day after FDA staff released pre-meeting papers that concluded the Chinese study used to support the drug's administration in first-line non-small-cell lung cancer (NSCLC) had several shortcomings and its results were not applicable to US patients.

Innovent and Eli Lilly should be required to conduct a trial of their lung cancer drug that is applicable to the US population, the AdCom recommended. "Single country submission is a step backward in achieving the racial diversity that we need in the United States," Richard Pazdur, director of the FDA's Oncology Center of Excellence, told the AdCom.