A panel of outside advisers to the US Food and Drug Administration on Thursday voted to recommend that Innovent Biologics Inc and Eli Lilly and Co be required to conduct a trial of their lung cancer drug that is applicable to the US population.
Data submitted to the FDA for approval consideration was from a clinical trial conducted only in China.
The vote recommending a new trial could be a harbinger for other large drugmakers such as AstraZeneca Plc and Roche Holding AG who have made big investments in the hopes of benefiting from cheaper trial costs in China.
The FDA is not required to follow the advice of its expert panels but typically does so.
In the late-stage trial conducted only in China, sintilimab met the main goal of progression free survival (PFS), or the time a patient lived without the disease worsening, for those with the most common form of advanced or recurrent lung cancer.
PFS was 9 months for sintilimab, administered with Lilly's cancer drug Alimta and platinum chemotherapy, compared with 5 months for those who got a placebo and the other two treatments in a trial involving 397 patients.
The advisory panel's recommendation is in line with the FDA's staff, who in briefing documents posted on Tuesday had noted that the patient population in the single-country trial does not reflect the diversity of the American population.
