The US 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.
The decision comes after a panel of advisers to the regulator in February recommended that Lilly and China-based Innovent should be required to conduct a trial of sintilimab that is applicable to the US population.
The US regulator in a so-called complete response letter recommended an additional multi-regional clinical trial. Lilly said along with Innovent it was assessing next steps for the sintilimab program in the United States.
Sintilimab, in the Chinese trial among 397 patients with advanced or recurrent nonsquamous non-small cell lung cancer, met the main goal of progression-free survival (PFS), or the time a patient lived without the disease worsening.
However, the FDA and its advisers had raised concerns over the lack of population diversity in a single-country trial and the use of PFS as the study’s main goal rather than overall survival, which is the gold standard for cancer drugs.
The agency’s decision on Thursday raises concerns for other Chinese drugmakers which have been seeking to bring their products to the US market at lower costs by conducting a single-country clinical trial.
Sintilimab, branded as Tyvyt in China, has been approved in the country for patients that have relapsed or are resistant to treatment for classic Hodgkin’s lymphoma after at least two lines of chemotherapy.
It is also cleared in China as a first-line treatment of nonsquamous non-small cell lung cancer in combination with Lilly’s cancer drug Alimta and platinum chemotherapy.