Cancer Research

U.S. FDA approves special protocol assessment for phase III PRECISE trial

Published in Medical Letter on the CDC and FDA, September 25th, 2005

NeoPharm, Inc., (NEOL) announced that the U.S. Food and Drug Administration (FDA) has approved an amendment to the company's special protocol assessment (SPA), which now includes an interim efficacy analysis of data from its pivotal phase III PRECISE trial of cintredekin besudotox for the treatment of glioblastoma multiforme (GBM).

During earlier discussions, the FDA suggested that NeoPharm consider proposing an interim efficacy analysis. The SPA already included two futility analyses and a final efficacy analysis.

An interim efficacy analysis will be conducted by the independent data monitoring committee (DMC), after notification of 160 deaths to...

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Source: Medical Letter on the CDC and FDA (2005-09-25)

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