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Draft Guidance for Industry - Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated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