Cancer Drug Approval Endpoints
- General Background Documents
- Multiple Myeloma Endpoints
- Ovarian Cancer Endpoints
- Primary Brain Tumor Endpoints
- Lung Cancer Endpoints
- Colorectal Cancer Endpoints
- Prostate Cancer Endpoints
- Acute Leukemia Endpoints
- 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
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.