Joint FDA, NCI program aims to streamline cancer drug development

FDA Consumer, July-August, 2003

The more than 1 million Americans who are diagnosed with cancer each year may soon benefit from a collaboration between the Food and Drug Administration and the National Cancer Institute (NCI).

"This new collaboration between two key HHS agencies means that federal researchers and regulators will be working together more effectively than ever before," says HHS Secretary Tommy G. Thompson. "The result will be a more unified, integrated, and efficient approach to the technology development and approval process at a critical time for a disease that affects too many lives."

Under an agreement announced in June, the FDA and the NCI, part of the National Institutes of Health, will share knowledge and resources to help develop new cancer drugs and speed their delivery to the people who need them. The agreement will enhance existing programs and add new joint programs to the current cooperative efforts of the two agencies, both part of the Department of Health and Human Services.

"The FDA is committed to finding better ways to get safe and effective treatments to patients with life-threatening diseases as quickly as possible," says FDA Commissioner Mark B. McClellan, M.D., Ph.D. "At a time when the opportunities to reduce the burden of cancer are greater than ever, sharing tools and resources with our colleagues at the National Cancer Institute will help us fulfill that mission," he says.

Areas in which the two agencies will collaborate include:

* Identifying biological responses (biomarkers) in the body that can be used to measure the effects of treatment to help evaluate new cancer medicines

* Addressing joint technology development issues, such as diagnostic imaging and molecular targeting

* Advancing the development and evaluation process for using natural or laboratory-made substances to prevent cancer (chemoprevention agents)

* Reviewing current policies to identify other ways in which FDA and NCI collaborations can enhance the development and regulatory process for cancer technologies

* Improving consumer awareness of choices about diet and nutrition and the consequences for cancer prevention

* Enhancing staff capabilities through collaborative training, joint rotations, and joint appointments.

The new partnership is an important step toward the NCI's goal to eliminate suffering and death due to cancer by 2015, as well as toward the FDA's goals of improving the availability and use of safe and effective treatments for cancer. "The bottom line is that this collaboration holds great promise for getting better cancer drugs to patients sooner," says NCI Director Andrew von Eschenbach, M.D. "Our job is to translate the promise of this unique collaboration into real benefit for patients as soon as possible."

Cancer Incidence Among Americans

* The leading cancer in men, regardless of race, is prostate cancer, followed by lung/bronchus and colon/rectal. Prostate cancer rates are 1.5 times higher in black men than white men.

* The leading cancer in women, regardless of race, is breast cancer, followed by lung/bronchus and colon/rectal in white women, and colon/rectal and lung/bronchus in black women. Breast cancer rates are about 20 percent higher in white women than in black women.

* Melanomas of the skin and cancer of the testis are among the top 15 cancers for white men, but not black men.

* Melanomas of the skin and cancer of the brain/other nervous systems are among the top 15 cancers for white women, but not black women.

* Multiple myeloma (cancer that arises in plasma cells) and cancer of the stomach are among the top 15 cancers for black women, but not white women.

* Multiple myeloma and cancer of the liver are among the top 15 cancers for black men, but not white men.

For more information:

Food and Drug Administration

www.fda.gov

National Cancer Institute

www.cancer.gov