Erbitux advisory committee in December?
Executive Summary
FDA's Oncologic Drugs Advisory Committee is tentatively scheduled to meet Dec. 16 and 17, with Bristol/ImClone's colorectal cancer agent Erbitux BLA one potential meeting topic. During an Oct. 23 conference call, Bristol noted that Erbitux has cleared one milestone already: FDA has formally accepted the application for filing this time around. The user fee action deadline is Feb. 14. Bristol is not anticipating any impact on the review from a Nov. 12 workshop on colorectal cancer endpoints (1"The Pink Sheet" Oct. 20, 2003, In Brief)...