FDA Panel Votes Against Lilly’s Lung Cancer Drug For China-only Trial

A U.S. Food and Drug Administration committee voted against full approval of Eli Lilly and Co.’s lung cancer treatment over concerns that the clinical trial was conducted only in China and that its results were not applicable to U.S. patients.

The monoclonal antibody treatment sintilimab injection in combination with pemetrexed and platinum chemotherapy is for the first-line treatment of people with nonsquamous non-small cell lung cancer. Sintilimab is jointly developed by Lilly and its Chinese partner Innovent Biologics Inc. The drug is already approved in China, under the brand name Tyvyt.

The Oncologic Drugs Advisory Committee or ODAC voted 14 to 1 to reject the new lung cancer drug saying the trial population in China of mostly Asian men did not represent the diversity of U.S. Patients, who are in various ethnic backgrounds.

The panel advising U.S. drug regulators further urged Lilly and Innovent Biologics to conduct additional clinical trials for FDA to approve the lung cancer immunotherapy.

Meanwhile, responding to FDA panel decision, Lilly said, “We had hoped that sintilimab could have played a positive role for patients and the U.S. healthcare system through an aggressive pricing strategy. … Lilly wholeheartedly agrees with the importance of ethics in clinical trial conduct and clinical trial diversity.”

Lilly and Innovent will continue to work with the FDA as it completes its review of the sintilimab application.

The final regulatory decision date to approve the drug in the U.S. is set for March 18. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

The drug is already approved in China, under the brand name Tyvyt, for the treatment of first line non-squamous non-small cell lung cancer, first line squamous non-small cell lung cancer and first line relapsed or refractory classic Hodgkin’s lymphoma.

For the third quarter of 2021, Lilly’s Tyvyt revenue in China was $125.6 million, up 49 percent over the year-ago quarter.

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