Erbitux expanded access program
Executive Summary
National Organization for Rare Disorders is administering expanded access program for Bristol-Myers Squibb/ImClone's Erbitux (cetuximab) for metastatic colorectal cancer patients ineligible for clinical trials. Thirty patients per month will be randomly selected to participate. The program began Feb. 6 in 20 cancer centers and will continue until thirty days after approval. Bristol expects to file a "comprehensive" Erbitux package with FDA in 2004 (1"The Pink Sheet" Sept. 23, 2002, p. 6)...