Sanofi oxaliplatin NDA
Executive Summary
Sanofi-Synthelabo submits final portion of rolling NDA for oxaliplatin as second-line treatment for advanced colorectal cancer June 24, company says. FDA's Oncologic Drugs Advisory Committee recommended against using the drug as first-line treatment in March 2000 (1"The Pink Sheet" Oct. 30, 2000, p. 32). FDA told a recent House hearing on ImClone that a randomized trial for a drug for the same indication as Erbitux "answered the question" of single-agent activity (2"The Pink Sheet" June 17, p. 7)...