FDA Workshop to Discuss Approval Criteria for Colorectal Cancer Drugs

The U.S. Food and Drug Administration has scheduled a workshop for November 12th at which the views of leading oncologists and researchers will be sought on the criteria for regular and accelerated approval of new colorectal cancer drugs.

Issues identified during the colon cancer workshop will be discussed by FDA’s Oncologic Drugs Advisory Committee at a meeting to be held sometime in early 2004.

For regular consideration of a drug as a first-line treatment for colorectal cancer, the FDA is asking whether an improved survival rate should be the only acceptable basis for approval.

"To date, regular approval has been based on a survival benefit, either a survival improvement or a survival non-inferiority analysis," the FDA said.

For drugs that are used along with first-line therapies, survival benefit (along with disease-free survival) has been the basis of approval, the FDA added. For advanced colorectal cancer, response rate and time to progression have supported accelerated approval in settings where there was no available effective therapy.

Participants in the workshop also will discuss several issues involving the design of clinical trials, such as frequent small survival benefits, the impact of crossover drugs, and the difficulty in establishing any added benefit in combination therapy.

The FDA also is asking workshop participants to identify colon cancer settings where benefits in relieving colorectal cancer symptoms could be the basis of drug approval, as well as the role of health-related quality-of-life in labeling claims.

Other sources: FDA