TITLE

FDA Wants Another Phase III For NeoPharm's GBM Drug

AUTHOR(S)
Morrison, Trista
PUB. DATE
March 2007
SOURCE
BioWorld Today;3/30/2007, Vol. 18 Issue 62, p2
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The author reports on the demand by the U.S. Food and Drug Administration (FDA) Office of Oncology for another phase III trial of cintredekin besudotox, before granting approval for its use in the treatment of recurrent glioblastoma multiforme. The drug failed to meet its primary endpoint in a Phase III trial in December 2006. The company said it is disappointed with the position of the Office of Oncology.
ACCESSION #
24572903

 

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