ASCO and the Food and Drug Administration, with support from the American Association for Cancer Research, are sponsoring a workshop March 22, on "Innovations in Breast Cancer Drug Development – Neoadjuvant Breast Cancer
," at FDA's White Oak Campus in Silver Spring, MD.
The 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The discussions at this workshop will be taken into consideration as the FDA moves to finalize the "Draft Guidance for Industry - Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval
ASCO President Sandra M. Swain, MD, FACP, and the FDA's Patricia Cortazar, MD, are co-chairs of the workshop.
There is no registration fee for the workshop, but for planning purposes, please register here