FDA declines to approve lung cancer drug

U.S. pharmaceutical company Eli Lilly announced on Thursday that the Food and Drug Administration declined approving its application for approval of a new cancer drug meant to treat nonsquamous non-small cell lung cancer.

Lilly’s drug called sintilimab is meant to be used in conjunction with chemotherapy as a first line of treatment for non-small cell lung cancer, according to the drug company.

In a letter to Lilly, the FDA apparently indicated that “the review cycle is complete but the FDA is unable to approve the application in its current form, consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in February.”

Sintilimab has been approved for use in China. The drug was developed by Lilly in partnership with Chinese biopharmaceutical company Innovent Biologics. Innovent has submitted sintilimab to be used in China for other forms of cancer as well, such as esophageal squamous cell carcinoma. 

Lilly’s application for sintilimab was based entirely on data from a study conducted in China. Last month, the FDA’s Oncology Drug Advisory Committee (ODAC) voted that more clinical trials were needed on the drug to demonstrate applicability to the U.S. population.

The FDA’s letter to Lilly also recommended that further clinical studies be conducted. Specifically, the agency recommended that a multiregional clinical trial comparing standards of care for non-small cell lung cancer to sintilimab for overall survival.

Lilly said it was assessing the next steps for sintilimab in the U.S.

As Endpoint News noted, Lilly is unlikely to be the only company affected by the FDA’s letter, as several other companies have submitted applications with data only coming from China.