Campath Leukemia Trial Vs. Alkylating Agents Could Confirm Approval - Cmte
Executive Summary
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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Berlex Campath-Fludara Combination Study In CLL Could Begin By Year-End
Berlex is considering study of the leukemia drug Campath in combination with its Fludara for the first-line treatment of patients with B-cell chronic lymphocytic leukemia.
Berlex Campath-Fludara Combination Study In CLL Could Begin By Year-End
Berlex is considering study of the leukemia drug Campath in combination with its Fludara for the first-line treatment of patients with B-cell chronic lymphocytic leukemia.
Ilex/Millennium Campath
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)