Big blow for Roche, as US FDA advisory panel votes to withdraw Avastin approval for breast cancer treatment

A US Food and Drug Administration advisory panel yesterday voted, by a massive 12 to one, to withdraw marketing authorization for Swiss drug major Roche's blockbuster cancer drug Avastin (bevacizumab) in combination with paclitaxel for previously untreated (first-line) advanced HER2-negative breast cancer.

Roche's shares fell 2.8% to 139 francs in today's morning trading on the Zurich exchange. The stock had already fallen 4.2% last week, after the FDA issued briefing documents ahead of the advisory meeting, saying that, according to the latest studies, Avastin did not slow breast cancer as much as previous trials had suggested.

The FDA's Oncologic Drugs Advisory Committee (ODAC) vote does not affect the current availability of Avastin for people with advanced HER2-negative breast cancer in the USA, where it is marketed by Roche's US subsidiary Genentech. However, given that it is an expensive treatment and the fact that insurers will be unlikely to cover an un-approved indication for the drug, it will see US sales drop substantially. The drug continues to be approved for lung and colon cancer.