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.
The advisers voted 14-1 that the agency require more data from the companies, which had previously only conducted a trial in China.
The FDA in briefing documents released on Tuesday had raised concerns over the lack of a diverse population tested in the study submitted for US approval consideration.
“Single country submission is a step backward in achieving the racial diversity that we need in the United States,” Richard Pazdur, director of the FDA’s Oncology Center of Excellence told the panel.
The panel’s vote 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.
Lilly, in a statement, 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.
Sintilimab, in the Chinese trial of patients with the most common form of 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, 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. (Reporting by Amruta Khandekar, Manas Mishra and Ankur Banerjee in Bengaluru; Editing by Bill Berkrot)