(Reuters) -The U.S. Food and Drug Administration has declined to approve Eli Lilly and partner Innovent Biologics Inc’s lung cancer drug that had been studied only in China, Lilly said on Thursday.
In its complete response letter to Lilly, the U.S. regulator said it was unable to approve the application in its current form and made a recommendation for an additional clinical study, specifically a multiregional clinical trial.
The decision comes after a panel of advisers to the regulator in February recommended that the companies should be required to conduct a trial of the drug, sintilimab, that is applicable to the U.S. population.
Along with Innovent, the company is assessing next steps for the sintilimab program in the United States, Lilly said.
(Reporting by Amruta Khandekar in Bengaluru; Editing by Shailesh Kuber)
