FDA Project on Cancer Drug Approval Endpoints

• General Background Documents
• Lung Cancer Endpoints
• Colorectal Cancer Endpoints
• Prostate Cancer Endpoints (7/1/2004)
• Contact Information

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

• Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products

• Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products [PDF] or [HTML] 

• End Points and United States Food and Drug Administration Approval of Oncology Drugs From:  Journal of Clinical Oncology 21:1404-1411. © 2003 by American Society of Clinical Oncology. Reprinted with permission from the American Society of Clinical Oncology.

• Background: Guidance for Industry: FDA Requirements for Approval of Drugs to Treat Non-Small Cell Lung Cancer (1991)
• Meeting Agenda
• Executive Summary of Workshop Discussion
• Workshop Participants
• Final Summary [Word] or [HTML]
• Meeting Presentations
  • Requirements for Drug Approval, Regular Approval Endpoints in Oncology, Grant Williams, MD, FDA.
  • Non-Small Cell Lung Cancer Approved First and Second Line Treatment, Martin Cohen, MD, FDA.
  • Endpoints Used Internationally, Renzo Canetta, MD, Bristol-Myers Squibb.
  • Advanced Non-Small Cell Lung Cancer, David H. Johnson, Vanderbilt University Medical School.
  • Non-Traditional Endpoints in Lung Cancer -  Patient Reported Outcomes, Richard J. Gralla, MD, New York Lung Cancer Alliance.

December 16, 2003 FDA Oncologic Drugs Advisory Committee Meeting on Lung Cancer Endpoints 

• Meeting Information  NOTE: The meeting will NOT be at the Bethesda Holiday Inn as stated in the Federal Register, rather it will be held at: Room 1066, CDER Advisory Committee Conference Room, 5630 Fishers Lane, Rockville, MD 20857

Colorectal Cancer Endpoints

May 4, 2004 FDA Oncologic Drugs Advisory Committee Meeting on Colorectal Cancer Endpoints   

• Meeting Information
• Meeting Announcement [PDF] or [HTML]

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

• Colorectal Cancer Endpoints Workshop Summary
• Meeting Announcement (11/7/2003)
• Meeting Agenda [Word] 
• Workshop Participants
• FDA Background for Colon Cancer Endpoints Workshop  
• Colon Cancer Workshop: Questions for Discussion [Word] 
• Meeting Presentations
  • Regulatory Background, Grant Williams, MD, FDA.
  • Design Issues in Colorectal Cancer Trials: Surrogates Endpoints and Non-Inferiority Trials, Thomas R. Fleming, Ph.D., University of Washington.
  • Past FDA Approvals in Colorectal Cancer, Amna Ibrahim M.D, FDA
  • Three Year Disease Free Survival (DFS) vs. Five Year Overall survival (OS) as an Endpoint for Adjuvant Colon Cancer Studies: Data from Randomized Trials, D. Sargent, et. al., Mayo Clinic.
  • Potential Use of Biomarkers or Quality of Life (QoL) Parameters in Colorectal Cancer Drug Approval, Charles D. Blanke, M.D., F.A.C.P., Oregon Health & Science University Cancer Institute.
  • Rectal Cancer Endpoints, Margaret Mooney, National Cancer Institute, NIH.
  • A Case for Time to Tumor Progression as a Clinical Benefit Endpoint in the First-line Therapy of Metastatic Colorectal Cancer, Langdon L. Miller, MD, PTC Therapeutics.

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

• Meeting Information
• Meeting Agenda  
• Questions for Discussion
• Panelists and Speakers
• Meeting Presentations (7/1/2004)

Dianne Spillman
Division of Oncology Drug Products (HFD-150),
Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857
Phone: 301-594-5746
Email: spillmand@cder.fda.gov.

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Date created: October 14, 2003, Updated: July 1, 2004

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