FDA Advisers Say Agency Shouldn’t Approve China-Developed Cancer Drug Now

The setback for Indianapolis-based Lilly and Chinese biotech company Innovent Biologics Inc. is a sign of a tougher U.S. stance on drugs that are tested only or predominantly in China.

FDA officials have recently cited concerns about the quality of drug studies conducted largely in China and whether the results can apply to patients in the U.S.

A final FDA decision on whether to approve the drug, named Tyvyt, is expected by the end of March. The FDA isn’t bound to follow the recommendations of its advisory panels but usually does.

Lilly said it was disappointed in the vote and was hoping to introduce Tyvyt drug at a lower price than comparable drugs in the U.S. The company and Innovent will work with the FDA as the agency completes its review of the drug. “Lilly wholeheartedly agrees with the importance of ethics in clinical trial conduct and clinical trial diversity,” the company said.

At the panel’s meeting, executives with Lilly and Innovent said the clinical trial in China demonstrated Tyvyt was effective in delaying tumor progression or death, with an acceptable safety profile.

They said that the study was well-conducted and that there was no reason to think the Chinese study’s results wouldn’t apply to U.S. patients.

Yet FDA officials made some unusually harsh criticisms of how the lung-cancer drug from Lilly and Innovent was tested in China.

FDA officials said that the results of the Chinese study testing Tyvyt weren’t applicable to U.S. patients—because of differences in medical practices between the countries—and that the study’s subjects didn’t reflect a diverse U.S. population.

The officials also said the study failed to test how Tyvyt performed against another lung-cancer drug that has become a standard treatment in the U.S.

Harpreet Singh, an FDA division director, said FDA inspectors found that researchers conducting the study at two sites in China underreported adverse events in patients. The study “only offers uncertainty,” she said.

Several members of the advisory panel, known as the Oncologic Drugs Advisory Committee, expressed agreement with the FDA concerns, saying they couldn’t assume the drug would have the same effect in a U.S. population as in China.

“I think it’s really hard to generalize this data,” said Dr. Ravi Madan, a panel member who is a clinical director at the National Cancer Institute. “From a clinical-trials standpoint, for me that’s a fundamental obstacle.”

Dr. Richard Pazdur, director of the FDA’s cancer-drugs division, said the agency is concerned about additional drugs that have been tested only or primarily in China.

He said the agency would prefer to see drugs that are tested in multiple regions and in trials that better reflect a diverse population in the U.S.

“The single-country trials are a step backwards,” Dr. Pazdur said. “This will come up with other trials emanating from China or other regions.”

He has said about 25 drugs developed in China are either up for FDA approval or on track to be filed for it.

Write to Peter Loftus at [email protected]