Roche May Lose US $1 Billion a Year on Probable Avastin FDA Ruling

regulators follow a panel recommendation to revoke approval of the drug for use in breast cancer.

Scientific advisers to the U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) voted 12-1 on July 20, 2010, to rescind Avastin's clearance in breast cancer, after finding the drug paired with chemotherapies did not work better than other medicines alone. Trial results that showed that a high dose of Avastin paired with chemotherapy extended the time patients lived without their disease worsening by 0.9 months, compared with treatment with chemotherapy alone; a lower dose of Avastin gave patients 0.8 months. A second trial found Avastin combined with anthracycline-based chemotherapies stalled tumor growth by 1.2 months, compared with treatment with chemotherapy alone.

Roche received FDA approval of Avastin for breast cancer in 2008 under an accelerated review that required that the company conduct trials proving that the drug slows progression of the disease; the FDA panel found that the tests failed to meet this goal. Drugs that win conditional clearance through the FDA's accelerated-approval program can later be pulled from the market if subsequent data fails to show that a treatment increases long-term survival or slows progression of the disease while improving quality of life. The panel also rejected Roche's application to expand use of Avastin in breast cancer for pairings with more varieties of chemotherapy.

"We are disappointed by the committee's recommendation and believe Avastin should continue to be an option," said Sandra Horning, M.D., head of clinical development hematology/oncology at Roche. "We will continue to discuss the data from the more than 2,400 women who participated in three phase III studies with the FDA."

Avastin is the first medicine to fight cancer by blocking the growth of blood vessels that feed tumors, a process called angiogenesis. It targets a chemical signal known as vascular endothelial growth factor (VEGF). The treatment, also approved for brain, lung and colon tumors, costs about $50,000 a year. Avastin sales are about $6.5 billion a year, including approximately $1.2 billion from breast cancer.

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