An FDA advisory panel has voted against the approval of a lung cancer immunotherapy drug developed and tested in China, The New York Times reported Feb. 10.
Five notes:
1. The drug in question is sintilimab, which goes by the brand name Tyvyt. It is a checkpoint inhibitor immunotherapy intended for use in combination with chemotherapy for patients with metastatic non-small-cell lung cancer. It was developed by Eli Lilly and its Chinese partner Innovent Biologics.
2. Sintilimab was tested only in China, a large factor in the advisory panel's vote against agency approval of the drug, the Times reports. The FDA has expressed concern about the quality of the clinical trial results and whether the results would be applicable to U.S. patients.
"We have nothing against drugs being developed in China," said Richard Pazdur, MD, director of the FDA's Oncology Center of Excellence. "Our issue is, are those results generalizable to the U.S. population?" he told The Wall Street Journal, adding that it is difficult to determine whether a drug would have the same benefits and safety profile in the U.S. when it is tested primarily in a single country.
3. The panel voted to recommend requiring another trial that would be applicable to U.S. patients in order to get the drug approved.
4. Eli Lilly and Innovent Biologics had planned to roll out the drug this year and sell it at a lower price than other immunotherapy drugs on the market.
5. In a Feb. 10 statement following the vote, Eli Lilly said it was disappointed with the outcome, but "appreciated the opportunity to publicly discuss the application and broader issues related to single-country clinical trials," adding that it will "continue to work with the FDA as it competes its review of the sintilimab application."