U.S. FDA advisers call for new trial of Lilly, Innovent lung cancer drug

By Amruta Khandekar and Roxanne Liu, Reuters 

Feb 10 (Reuters) – Innovent Biologics Inc (1801.HK) and Eli Lilly and Co (LLY.N) should be required to conduct a trial of their lung cancer drug that is applicable to the U.S. population, a panel of advisers to the U.S. Food and Drug Administration recommended Thursday.

The recommendation, which sent Innovent shares down more than 10% on Friday, raises concerns for some other Chinese drugmakers who have been seeking to bring their products to the U.S. market at lower costs by conducting a single-country clinical trial.

There are at least 25 applications from China in drug development phases, planned to be submitted or already under review by the FDA, that are predominantly or solely based on trial data from China, the FDA said ahead of the panel vote, without naming the products.

“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 panel.

The outside expert panel voted 14-1 that the FDA require more data from Innovent and Eli Lilly which had conducted the trial only in China.