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FDA Project on 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.
- Meeting Information
- Agenda
- Panelists
- Presentations
- Workshop on Clinical Endpoints in Multiple Myloma, Kenneth C. Anderson MD, Dana-Farber Cancer Institute. [PDF]
- FDA Approvals in Multiple Myeloma, Anne Farrell, MD, FDA [PDF]
- Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma, Robert A. Kyle MD, Mayo Clinic [PDF]
- Newly Diagnosed Myeloma, S. Vincent Rajkumar MD, Mayo Clinic [PDF]
- Maintenance Therapy, Keith Stewart MD, Mayo Clinic [PDF]
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.
- Meeting Information
- Agenda
- Meeting Summary
- Background Information
- Panelists
- Questions to the Panel
- Potential Biomarker and
Endpoint Research Priorities
- Meeting Presentations
Regulatory Background [PDF] Lee Pai-Scherf, MD, FDA
Design Issues in Clinical Trials of Ovarian Cancer
- Design Issues in Clinical Trials of Ovarian Cancer, Tate
Thigpen, University of Mississippi, Presentation [PDF]
Text of Talk [PDF]
Regulatory Use of CA-125
- Use of CA-125 for Response Evaluation in Ovarian Cancer [PDF],
Robert Bast, MD Anderson Cancer Center and Gordon Rustin, Mt.
Vernon Cancer Center, Eng.
- FDA Perspective: Analytical Aspects of CA Aspects of CA-125 T
[PDF] Robert L. Becker, Jr.
MD, PhD, FDA
Regulatory Endpoints for First-Time Therapy
- Is PFS a “valid”surrogate for OS in advanced ovarian cancer? A
meta-analysis [PDF] Marc Buyse,
Institut National du Cancer, Paris, France
- Clinical Trial Endpoints for Regulatory Approval Regulatory
Approval: First First-Line Therapy for Line Therapy for Advanced
Ovarian Cancer [PDF]
Elizabeth Eisenhauer MD, FRCPC
- First-line therapy in Ovarian Cancer: Surrogate endpoints for
accelerated approval [PDF] Mark F.
Brady, PhD, GOG Statistical and Data Center
Regulatory Endpoints for Maintenance Therapy
- Maintenance Therapy in Ovarian Cancer: PFS and OS as Endpoints
of Therapeutic Clinical Trials [PDF]
Robert F. Ozols, MD, PhD, Fox Chase Cancer Center
David R. Spriggs, MD, Memorial Sloan-Kettering Cancer Center
Regulatory Endpoints for Subsequent Therapies
- Endpoints in Ovarian Cancer Clinical Trials: Recurrent Disease
[PDF] David Spriggs,
Memorial Sloan-Kettering Cancer Center
PROs
- Patient-Reported Outcomes: End Points for Ovarian Cancer [PDF]
Lari Wenzel, Ph.D, UC Irvine, and Karen Basen-Engquist, Ph.D. MD
Anderson Cancer Center
NCI Session
- Biomarker & Endpoint Research Priorities [PDF]
Edward Trimble MD, MPH, NCI/CTEP
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)
- 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
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
- 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.
- May 4, 2004 (PM) FDA Oncologic Drugs Advisory Committee Meeting on
Colorectal Cancer Endpoints
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
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Date created: October 14, 2003, Updated: April 20, 2007 |
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