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A US Food and Drug Administration panel has recommended against the approval of a lung cancer therapy that was tested only in China, CNBC reports. The panel said, it adds, that as the study only included Chinese men, it does not represent the diversity of the US population.

The Wall Street Journal reported earlier this week that the FDA appeared to be shifting away from a previous stance it took on drugs developed in China. It noted that the agency approved BeiGene's Brukinsa (zanubrutinib) for lymphoma in 2019 based largely on studies conducted in China and that Richard Pazdur, director of FDA's Oncology Center of Excellence, said then that the agency would accept Chinese drug trial results. But the Journal noted that regulators seemed to have developed concerns that such trials would not translate to a US population.

As CNBC reports, an FDA advisory committee voted 14 to 1 against approving the monoclonal antibody treatment sintilimab from Eli Lilly and Innovent Biologics that was tested only in clinical trials in China. Pazdur tells it that clinical trials need to be racially diverse. "Single countries submissions is a step backward in achieving the racial diversity that we need in the United States," he adds there.

In a statement, Lilly says it is "disappointed," but that it "appreciated the opportunity to publicly discuss the application and broader issues related to single-country clinical trials." It adds that it agrees with the need to have diverse trials and will work with FDA as it reviews its application.