FDA Public Workshop: Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer Workshop

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The discussions at this workshop will be taken into consideration as the FDA moves to finalize the Draft Guidance for Industry - Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated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

Draft Agenda (PDF - 49KB)¹

Registration

There is no registration fee for the workshop, but for planning purposes, please register at the following site: http://s.zoomerang.com/Survey/WEB22GMA2S22N6²

.³ Confirmation of your registration will be sent by ASCO's Eden Mesfin (eden.mesfin@asco.org).

General Information

Lodging, transportation, driving directions, parking, and security information is available at: Public Meetings at the FDA White Oak Campus⁴

Background Information

Draft Guidance for Industry - Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval⁵ [PDF]

For Further Information, Contact

Dianne Spillman
Oncology Program
Office of Hematology & Oncology Products (OHOP),
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration
Phone: 301-796-1647
E-mail: dianne.spillman@fda.hhs.gov