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Role of Newly Approved Avastin In Glioblastoma Divides Experts

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The fact that Avastin's clearance under FDA's accelerated approval pathway rested on two single-arm trials raises questions for some about whether it can really be considered the standard of care, yet it is anecdotally reported as coming into ever wider use in the U.S. ("Avastin Clinical Benefit Trumps Anti-tumor Effect In Glioblastoma, ODAC Says," "The Pink Sheet" DAILY, April 6, 2009). Phase III trials are under way, but results won't become available until 2014.

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