Ilex/Millennium Campath
Executive Summary
The user fee deadline for chronic lymphocytic leukemia treatment Campath is May 19, Ilex reports, after FDA accepts response to Feb. 20 "complete review" letter. Phase IV study of Campath (alemtuzumab) vs. alkylating agent chlorambucil is under discussion with FDA. The trial design and final labeling negotiations are the only remaining issues for approval (1"The Pink Sheet" Feb. 26, In Brief)