Will FDA care about new Avastin study?

Will a new Avastin-in-breast-cancer study persuade the FDA? Genentech hopes so. The company said a new study, sponsored by partner Roche, showed that the drug staved off progression of the disease. Though the study wasn't included with the official app for FDA approval, some analysts say it may help Genentech's case anyway.

You'll recall that last year, an FDA advisory committee voted [1] against expanding Avastin's use to breast cancer. A previous study showing slowed disease progression wasn't enough to outweigh the drug's side effects, the committee said. Researchers speculated that Avastin might make tumors resistant to other cancer drugs, or might make the tumor grow more aggressively once treatment ends.

The new study hasn't gone on long enough to show whether women on Avastin actually live longer. Some analysts think the FDA will wait for that sort of data before giving Avastin a new thumbs-up. The agency is scheduled to decide by Feb. 23.

- check out Genentech's release [2]
- see this New York Times article [3]
- here's a report [4] from the Houston Chronicle
- read the item [5] in the Wall Street Journal Health Blog

Related Articles:
EU blesses Avastin for broader use. Report [6]
FDA: Avastin lackluster in breast cancer. Report [1]
Avastin re-submitted to FDA. Report [7]
Avastin encounters rare failure for pancreatic cancer. Report [8]