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U.S. Department of Health and Human Services

About FDA

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Cancer Drug Approval Endpoints

The Food and Drug Administration is undertaking a project to evaluate potential endpoints for cancer drug approval. Endpoints will be examined for the most common cancers, such as lung cancer, colon cancer, etc. For each cancer, FDA will hold public workshops to identify important issues, and these issues will be discussed in meetings of the Oncologic Drugs Advisory Committee (ODAC). Subsequently, guidance documents will be published describing FDA's current thinking on endpoints for cancer drug approval.

Workshop planning will be guided by a steering committee that includes representation from the FDA, the National Cancer Institute, the American Society of Clinical Oncology, and the American Association for Cancer Research. Workshop participants will include oncology experts, radiation oncologists, statisticians, industry representatives, and patient advocates.

Listed below will be agendas, background materials, meeting transcripts, and links providing additional information on workshops and ODAC meetings.

 General Background Documents


 Multiple Myeloma Endpoints

FDA and the American Society of Hematology (ASH), with co-sponsorship by the American Society of Clinical Oncology (ASCO) and the American Association for Cancer Research (AACR), are holding a public workshop on endpoints for multiple myeloma. Issues identified in the workshop will be further discussed before the Oncologic Drugs Advisory Committee (ODAC) and thereafter will be detailed in FDA Guidance Documents. The meeting will be held on October 26, 2006 in Washington, DC.


 Ovarian Cancer Endpoints

FDA and the American Society of Clinical Oncology (ASCO), with co-sponsorship by the American Association for Cancer Research (AACR), public workshop on endpoints for ovarian cancer, April 26, 2006, 7:30 to 5:00 pm, North Bethesda, Maryland.


 Primary Brain Tumor Endpoints

AACR/FDA Public Workshop on Clinical Trial End Points in Primary Brain Tumors, January 20, 2006, 8:00 a.m. to 4:00 p.m. North Bethesda, MD 4:00 to 5:00 pm, Optional Session: NCI Research Priorities.


 Lung Cancer Endpoints

American Society of Clinical Oncology/FDA Lung Cancer Endpoints Workshop (April 15, 2003)


 Colorectal Cancer Endpoints

FDA Public Workshop on Clinical Trial Endpoints in Colorectal Cancer, November 12, 2003, 8:00 a.m. to 5:00 p.m., Washington DC.


 Prostate Cancer Endpoints

FDA Public Workshop on Clinical Trial Endpoints in Prostate Cancer, June 21-22, 2004, 8:00 am -5:00 pm, Bethesda, MD  


 Acute Leukemia Endpoints

FDA Workshop on Clinical Trial Endpoints in Acute Leukemia, June 24, 2005, 8:30 am – 5:00 pm, Washington, DC


 For further information, contact:

Dianne Spillman
Office of Oncology Drug Products (HFD-150),
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Avenue, Silver Spring MD
Phone: (301) 796-1467
Email: dianne.spillman@fda.hhs.gov