FDA 'Unclear' If Genentech Drug Data Backs Expanded Approval
28 March 2009 - 1:35AM
Dow Jones News
The Food and Drug Administration said it's "unclear" whether
positive responses seen in clinical trials involving Genentech
Inc.'s (DNA) Avastin are sufficient to support accelerated approval
of the drug to treat an aggressive type of brain cancer.
Genentech is seeking FDA approval to market Avastin, already
approved to treat advanced breast, lung and colorectal cancer, for
patients who suffer from an aggressive form of brain cancer in
which the survival rate is 9 months to 12 months.
A panel of outside medical experts will discuss Avastin at an
FDA sponsored meeting Tuesday. The panel will decide whether to
recommend approval to expand the drug to treat brain cancer. The
FDA generally follows the group's advice.
The FDA said it's "unclear weather the response rate and
duration of response seen" in Genentech's application are
sufficient, according to briefing documents posted on the agency's
Web site.
-By Jared A. Favole, Dow Jones Newswires; 202.862.9207;
jared.favole@dowjones.com