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Cancer Drug Approval Sought

Genentech asks the FDA to act on Avastin by March. Analysts say the drug's annual revenue could exceed $1 billion.

September 30, 2003|Denise Gellene | Times Staff Writer

Biotechnology giant Genentech Inc. said Monday that it had submitted a 60,000-page application to the Food and Drug Administration for permission to sell its experimental cancer drug Avastin.

If the FDA approves the drug, it will become the first in a class of medications called angiogenesis inhibitors -- drugs that attack tumors by pruning the blood vessels that feed them. Analysts say annual sales of Avastin could exceed $1 billion.

The world's second-largest biotechnology company said it had asked the FDA for a "priority review," a designation that would give the agency until the end of March to make a decision on Avastin.

Genentech's shares closed down 39 cents at $80 on the New York Stock Exchange on Monday. The company's shares have more than doubled since May 19, when Genentech announced that Avastin, when used in combination with chemotherapy, added an average of five months to the lives of colon cancer patients in a large clinical trial.

Avastin is a synthetic antibody that blocks a protein called VEGF, or vascular endothelial growth factor. The protein plays an important role in blood vessel formation and was discovered at Genentech, which owns rights to the drug.

Colon cancer is the second-leading cause of cancer death, next to lung cancer, and 147,500 cases are diagnosed each year. South San Francisco-based Genentech also is testing Avastin for possible treatment of other cancers.

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