F.D.A. Rejects Closely Watched Lung Cancer Drug From China

详细摘要

The treatment, called ivonescimab, has become a symbol of China’s rise in drug development.

The Food and Drug Administration rejected a first-of-its-kind cancer drug that was invented in China, a setback for a medicine that had become a symbol of China’s ascendance as a powerhouse in drug development.

Summit Therapeutics, the Florida company that has been seeking to bring the drug to the American market, disclosed the agency’s decision in a news release on Sunday. Summit bought the U.S. rights to the drug from Akeso Biopharma, a Chinese drugmaker that invented the drug in its laboratories and sells it in China.

Summit had been seeking approval only for certain patients with advanced lung cancer. But the drug had raised high hopes because it is being tested in many more cancers, including tumors of the colon, bladder and breast.

Summit said on Sunday that the F.D.A. told the company it had rejected the drug because it had not shown a statistically significant benefit in prolonging patients’ lives in the global clinical trial that was the basis of Summit’s application.

Summit had been seeking F.D.A. approval based on the results of a study the company conducted in the United States, Canada, Europe and Asia that enrolled patients who had already tried a targeted treatment. The trial compared patients who received ivonescimab and chemotherapy with those whose only treatment was chemotherapy. In that study, the drug was successful in delaying the cancer’s progression.

Summit has argued that the failure to extend patients’ lives simply reflected slow enrollment in the study. Hoping to bolster its case, the company had sent the F.D.A. analyses that were not specified in the original research plan of patients’ longer-time outcomes, but those were not enough to persuade regulators.

文章开头，摘自DealBook (The New York Times)。如需阅读全文，请前往媒体网站。