To: Oncologic Drugs Advisory Committee Members and Guests
From: Richard Pazdur, M.D.
Director, Division of Oncology Drug Products, CDER, FDA
memo outlines the purpose of the afternoon session of the
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.
afternoon session of
Documents in this background package include:
General background document:
TAB 1 Endpoints that have supported cancer drug approval (JCO article)
TAB 2 Executive summary of workshop discussion
Please also refer to the FDA endpoints web page for additional background documents and slides from the November 2003 colorectal cancer workshop presentations