Revista Salud y Bienestar

FDA panel recommends withdrawing Avastin as breast cancer treatment

Por Fat
An FDA panel on Tuesday voted 12-1 to recommend to the agency that Roche's Avastin (bevacizumab) should no longer be approved for use in patients with breast cancer. Analysts noted that if the breast cancer indication for the drug were to be removed, it could reduce annual sales by about $1 billion.
The panel also voted 13-0 that a post-approval study of the drug failed to prove that the risks and adverse effect profile associated with use of Avastin in combination with docetaxel did not outweigh its benefits in this patient cohort and voted 12-1 against the same question in regards to Avastin in combination with other chemotherapy drugs. The recommendations echo those discussed in FDA staff review documents posted to the agency's website last week.
As a condition of its 2008 approval of Avastin, Roche was required to conduct follow-up studies to demonstrate the benefits of the drug when used in combination with conventional chemotherapy. However, two follow-up studies demonstrated that progression-free survival averaged 2.9 months, down from a median of 5.5 months observed in the initial study, and patients also reported significant side effects, including high blood pressure and fatigue.
Commenting on the data, Natalie Compagni Portis, the panel's patient representative, noted that "the study shows there's very little benefit to patients with significant toxicity risks and no clear survival benefit." However, Roche noted that it stands by its data demonstrating that Avastin provides a benefit for patients with advanced breast cancer, noting that "Avastin should be an option for patients with this incurable disease." The FDA will make a decision on the use of the drug in this indication by September 17.
The drug has global sales of $5.9 billion.
Reference Articles
Roche’s Avastin fails to win FDA panel backing in breast cancer - (Bloomberg)
US panel rejects Roche's Avastin for breast cancer - (Forexpros)
Genentech provides update from Avastin FDA Advisory Committee meeting - (Genentech)
Genentech disappointed with FDA panel on Avastin - (MarketWatch)
FDA panel: Avastin adds no benefit to chemotherapy for breast cancer - (SmartMoney)
Panel urges FDA to revoke approval of drug for breast cancer treatment - (The New York Times)
FDA panel urges Avastin be disallowed as breast cancer treatment - (USA Today)
FDA panel: Study did not show benefit with Avastin - (Yahoo!News)
**Published in "First Word"

Volver a la Portada de Logo Paperblog