FDA Panel Rejects Lilly Cancer Drug Tested Only in China

Generic vials.
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Drug was to be used alongside chemotherapy for patients with metastatic non-small cell lung cancer

HealthDay News — A new lung cancer drug that has only been tested in China was soundly rejected by an advisory panel to the US Food and Drug Administration on Thursday.

Known as sintilimab, the treatment is a type of immunotherapy. It was developed and tested in China by Innovent Biologics, which entered into an agreement with Eli Lilly that would have allowed Lilly to seek approval to market the drug in the United States, The New York Times reported. It was to be used alongside chemotherapy for patients with metastatic non-small cell lung cancer.

“We had hoped that sintilimab could have played a positive role for patients and the US health care system through an aggressive pricing strategy,” Lilly said in a statement released Thursday. “Along with Innovent, we will continue to work with the FDA as it completes its review of the sintilimab application.”

Richard Pazdur, MD, who heads the FDA oncology unit, explained on Thursday why he had backtracked from a far more welcoming attitude in 2019, when he said the agency might consider a drug tested solely in China. “Over the past 2 or 3 years, this country has experienced tremendous social change,” he said during the meeting, The Times reported, and diversity in clinical trial participants has become a critical issue. A drug tested only in China is “a step backward,” he added.

More troubling was the results of an FDA staff analysis that skewered the methodological grounds of the Chinese trial, The Times reported. It cited a failure to provide patients in the control group with an approved therapy that is standard of care; questioned the competence and experience of some of the investigators; noted a patient population that was younger, had more men, and had fewer smokers than typical US lung cancer patients; and criticized use of an end point that is not always reliable.

Lilly had promoted its FDA application by saying that it wanted to use sintilimab as a wedge to break the sky-high prices of many cancer immunotherapies.

The New York Times Article