Question

The drug cabozantinib is an approved and marketed drug for a type of kidney cancer. Exelixis successfully showed in clinical trials that cabozantinib is also effective for a type of liver cancer. Which type of drug marketing application will it file with the FDA for permission to market the drug for liver cancer?

-Over-the-counter drug application
-Supplemental New Drug Application
-Biologics license application
-Abbreviated new drug application
-Orphan drug application

Answer 1

Exelixis would file a Supplemental New Drug Application (sNDA) with the FDA to market cabozantinib for liver cancer after its approval for kidney cancer.

Step-by-step explanation:

To market cabozantinib for liver cancer after it has already been approved for kidney cancer, Exelixis would need to file a Supplemental New Drug Application (sNDA) with the Food and Drug Administration (FDA). An sNDA is submitted for an existing approved drug when there is a proposed change to the labeling, formulation, or dosage, or if there is a new indication for use.

Since cabozantinib is effective for a type of liver cancer and has already been approved for kidney cancer, this application is appropriate to extend its marketing to include treatment for liver cancer.