On Thursday, a committee of the Food and Drug Administration voted against the full approval for a treatment for lung cancer developed by Innovent Biologics and Eli Lilly. This was due to concerns that the trial was only conducted in China and involved participants who weren’t as diverse than the U.S.  

In a vote of 14 to 1, the FDA’s Oncologic Drugs Advisory Committee said that companies need additional clinical trials that are representative of U.S. patients. Sintilimab, a monoclonal antibody therapy, is used to treat non-small-cell lung cancer. It can also be combined with chemotherapy.  

FDA members claimed that patients from the United States were not represented in the trials population, making it impossible to judge whether these results will be valid.

Lung cancer cases in the U.S. can be found among patients of all ages and from different backgrounds. The study found that the patients were younger than the people with lung cancer who have been diagnosed in the U.S. and were less likely to be current or former smokers.

David Mitchell, founder of Patients for Affordable Medicines, stated that the FDA and industry want to improve diversity in clinical trials in order to make sure they represent the patients being treated.   

Richard Pazdur (director of FDA’s Oncology Center of Excellence) stressed the importance of performing clinical trials in many countries, to make sure they reflect racial diversity. The goal is to not exclude China from drug development, but instead bring it in the international fold.

Pazdur stated that single-country submissions are a backward step in attaining the diversity of racial origins needed in America.

Innovent head of regulatory affairs Dr. Lana Shiu stated that the drug sintilimab can be tolerated well and has a substantial benefit in patients suffering from multiple cancer types. Eli Lilly head of the oncological medical strategy, Dr. David Ferry stated that there is no impact on how effective sintilimab can be on race or body weight.

The trial did not provide any treatment options or allow for participation in other studies, according to the committee members.

Ravi Madan is a National Cancer Institute clinical director. “Data integrity in clinical research is very important, but moral integrity even more so,” she said. Madan stated that the informed consent form wasn’t updated during the trial.

The FDA was not notified by the companies at all during the clinical trial. While the FDA began the clinical trial in August 2018, it was only informed about the findings by the FDA when they submitted them. 

Jorge Garcia, a doctor specializing in cancer said that he was disappointed by the lack of communication between the sponsor and applicant at an early stage during trial design. I would love to think that these meetings wouldn’t have led us to this discussion.

According to Dr. Harpreet, an FDA director in the Office of Oncologic Diseases Office, investigators found that there was underreporting of adverse incidents at two of the sites inspected during the trial. Singh stated that trial personnel were taught the importance of maintaining good records to avoid future problems.

Dr. Jorge Nieva voted against, stating that the drug is effective and offers more value than chemotherapy. Nieva stated that although other drugs for lung cancer are available, approval of more would lower prices and allow more patients to access them.

Nieva, who is a professor at Keck School of Medicine at University of Southern California, said that there was no evidence to suggest the data presented were unreliable, fake, or fraudulent. “We had adequate FDA inspections, which weren’t hampered. “If more inspections were necessary, it’s expected that the FDA will have conducted them,” he stated.