Co-sponsored by the:
U.S. Food & Drug Administration (FDA) & American Society of Clinical Oncology (ASCO)
with support from the American Association for Cancer Research (AACR)
Co-Chairs: Dr. Sandra Swain and Dr. Patricia Cortazar
This workshop will provide a forum to discuss issues related to breast cancer drug development in the neo-adjuvant setting. The topics will include: (1) how Neoadjuvant trials can expedite drug development, (2) the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) meta-analysis results, and (3) the draft FDA Guidance for Industry: Use of Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early Stage Breast Cancer as an Endpoint to Support Accelerated Approval.
The discussions at this workshop will be taken into consideration as the FDA moves to finalize the Draft Guidance for Industry - Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval.
Date: March 22, 2013
Time: 8:00 a.m. to 5:00 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Avenue,
Bldg. 31, Room 1503 (Great Room)
Silver Spring, Maryland 20993
There is no registration fee for the workshop, but for planning purposes, please register at the following site: http://s.zoomerang.com/Survey/WEB22GMA2S22N6 . Confirmation of your registration will be sent by ASCO's Eden Mesfin (email@example.com).
The Center for Drug Evaluation and Research (CDER) provided a webcast of the March 22, 2013, Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop.
A recording of the webcast can be found at the following:
- Start of Meeting to Morning Break: https://collaboration.fda.gov/p91363292/
- Morning Break to Lunch: https://collaboration.fda.gov/p48233712/
- Lunch to End of Meeting: https://collaboration.fda.gov/p92054293/
The webcast will be broadcast using Adobe Connect. You can check to determine if your computer has the correct plug-ins in order to view the webcast by accessing the following web site: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
To access a quick overview summary of the Adobe Connect software visit: http://www.adobe.com/go/connectpro_overview
For further information regarding webcasts and archived webcasts, and for contact information of staff available to assist with questions, and lodging, transportation, driving directions, parking, and security information is available at: Public Meetings at the FDA White Oak Campus
- Draft Guidance for Industry - Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval [PDF]
- TM Prowell and R Pazdur. Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer. N Eng J Med. 2012 Jun 28;366(26):2438-41
For Further Information, Contact
Office of Hematology & Oncology Products (OHOP),
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration
- Introduction by Patricia Cortazar, M.D. (PDF - 648KB) [ARCHIVED]
- Wrap up/Summary by Sandra Swain, M.D. (PDF - 579KB) [ARCHIVED]
- José Baselga, M.D., Ph.D. (PDF - 414KB) [ARCHIVED]
- Patricia Cortazar, M.D. and Lijun Zhang, Ph.D. (PDF - 532KB) [ARCHIVED]
- Terry Mamounas, M.D. (PDF - 538KB) [ARCHIVED]
Tatiana M. Prowell, M.D.(PDF - 131KB) [ARCHIVED]