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)
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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)
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials