Avastin Clinical Benefit Trumps Anti-Tumor Effect In Glioblastoma, ODAC Says
Demonstration of an anti-tumor effect is not essential for a brain cancer indication if clinical benefit is provided, FDA's Oncology Drugs Advisory Committee indicated March 31 in recommending accelerated approval of Genentech's Avastin to treat relapsed glioblastoma multiforme
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Current and former chairs of FDA’s Oncologic Drugs Advisory Committee debate the usefulness of the public hearing and its impact on committee deliberations.
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.