The US Food and Drug Administration has approved Avastin for the treatment of breast cancer, Genentech announced. Most industry watchers had expected the FDA to delay a decision or reject the medicine for this use.
Most industry watchers had expected the FDA to delay a decision or reject the medicine for this use. Avastin, also known by its generic name bevacizumab, has already been approved to treat colon and lung cancer.

The FDA decision comes after the US biotechnology company released study findings last week that Avastin in combination with chemotherapy significantly prolonged the progression-free survival in breast cancer patients.

An FDA advisory panel in December had narrowly voted to recommend rejecting Avastin for breast cancer, saying data from an earlier study were insufficient to establish that the benefits of the drug outweighed toxicity risks in this patient population.

Bevacizumab is one of a new class of drugs that block the formation of blood vessels that supply the cancerous tumors, shutting off its source of nourishment. The agent is a genetically engineered 'monoclonal antibody' that binds to and inhibits the activity of human vascular endothelial growth factor (VEGF), which is necessary for blood vessel growth.

The drug was approved to be taken with paclitaxel for the treatment of patients with advanced breast cancer who have not started chemotherapy. A study conducted by Roche, Inc., which is working with Genentech, tested Avastin in combination with a different chemotherapeutic drug.

"With Avastin plus paclitaxel, we can increase the time a woman's cancer is kept under control, and offer a biologic option to women who previously were limited to chemotherapies alone," Dr. Kathy Miller, who led one of the pivotal Avastin breast cancer studies, said in a statement.

The business community had become wary that a more conservative FDA was going to start requiring overall survival data before approving any cancer treatments. That is considered to be a much higher bar than progression-free survival data -- or time patients live without their disease advancing.

(Additional reporting by Kim Dixon in Washington)