Genentech, Inc. announced today that the U.S. Food and Drug
Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted
unanimously that the response seen with Avastin®
(bevacizumab) in people with previously treated glioblastoma is of
sufficient magnitude to be reasonably likely to predict clinical
benefit. The FDA is expected to make a decision whether to grant
accelerated approval of Avastin for use in this most aggressive form of
brain cancer by May 5, 2009.
“We look forward to working with the FDA to potentially provide people
with this devastating disease the first new treatment in more than a
decade,” said David Schenkein, M.D., senior vice president, Clinical
Hematology and Oncology, Genentech. “A global Phase III trial evaluating
Avastin in people with newly diagnosed glioblastoma will be initiated
later this year.”
About Glioblastoma
Glioblastoma affects approximately 10,000 people per year in the United
States. Following initial treatment, glioblastoma tumors nearly always
return and there are currently no widely accepted non-surgical medicines
when these relapses occur. According to historical estimates, fewer than
10 percent of patients respond to treatment and approximately 10 to 20
percent will live six months without their disease getting worse.
Glioblastoma tumors invade brain tissue and can impact physical
activities and mental abilities.
Avastin Application for Accelerated Approval
An accelerated approval of Avastin for previously treated glioblastoma
would provide doctors with safety and efficacy information and give
people with this rapidly progressing brain cancer a new option. The
application is based on positive, independently reviewed data from the
non-comparative Phase II BRAIN study (AVF3708g) of 167 patients. In the
85 patients treated with Avastin alone, the trial showed:
-
In 28 percent, tumors shrank to at least half their original size;
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In those whose tumors shrank, half experienced a response of at least
5.6 months;
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43 percent lived six months without their disease getting worse; and,
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Half lived at least 9.3 months after starting treatment with Avastin
and 38 percent survived longer than one year.
No new safety signals were observed in the trial and the safety profile
was consistent with Avastin experience in other tumor types.
