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Ilex/Millennium Campath

Executive Summary

Design of post-approval commitment trial under discussion with FDA following receipt of "complete review" letter for the chronic lymphocytic leukemia treatment, Millennium reports. Campath is on track for approval in first quarter, the company says. FDA's Oncologic Drugs Advisory Committee voted 14-1 in favor of accelerated approval of alemtuzumab but was undecided on the design of the post-approval comparative study (1"The Pink Sheet" Dec. 18, 2000, p. 17)

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Ilex/Millennium Campath

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)

Ilex/Millennium Campath

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)

Campath Leukemia Trial Vs. Alkylating Agents Could Confirm Approval - Cmte

Comparing Millennium/Ilex' Campath to alkylating agents that are second-line to Berlex' Fludara in the treatment of chronic lymphocytic leukemia could be an option for a confirmatory trial under accelerated approval, FDA's Oncologic Drugs Advisory Committee suggested Dec. 14.

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