China’s Innovent Biologics and pharma giant Eli Lilly and Co should be required to conduct a trial of their lung cancer drug that is applicable to the US population, a panel of advisers to the Food and Drug Administration recommended on Thursday.
The recommendation, which sent Innovent shares down more than 10% on Friday, raises concerns for other Chinese drugmakers who have been seeking to bring their products to the US market at lower costs by conducting clinical trials in China.
There are at least 25 applications in drug development phases, planned to be submitted or already under review by the FDA, that are predominantly or solely based on trial data from China, the FDA said ahead of the panel vote, without naming the products.
“Single country submission is a step backward in achieving the racial diversity that we need in the US,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence, told the panel.
The outside expert panel voted 14-1 that the FDA require more data from Innovent and Eli Lilly which had conducted the trial only in China.
Lilly said it was “disappointed” with the outcome of the advisory panel meeting, but that it would continue to work with the FDA as the agency completes its review of sintilimab.
“We have long-standing initiatives in place to advance diversity and inclusion in Lilly-conducted clinical trials,” it said in a statement.
Innovent said it is confident in sintilimab, which in its Chinese trial of patients with the most common advanced or recurrent lung cancer, met the main goal of progression free survival (PFS), or the time a patient lived without the disease worsening.
In addition to the lack of population diversity, experts raised concerns over the use of PFS as the study’s main goal rather than overall survival, the gold standard for cancer drugs.
They also noted a lack of urgency for this medicine, given the availability of other effective drugs from the same class of immunotherapies, known as PD-1 inhibitors, such as Merck & Co’s Keytruda and Bristol Myers Squibb’s Opdivo.
Jorge Nieva, a panel member from the University of Southern California and the lone dissenter, said another drug on the market sooner could help lower the cost of such treatments.
“Having more drugs competing for those patients will have greater impact on health equity than the need for diversity in clinical enrolment,” he said.
- Reuters, with additional editing by George Russell
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