Genentech Cancer Drug on ‘Fast Track’
Genentech Inc.’s much- anticipated experimental biotechnology cancer drug Avastin has received “fast-track” status from the Food and Drug Administration, the company said.
The designation means the medication could reach the market by late this year.
The company had announced the news after the markets closed Thursday. Genentech’s shares rose 85 cents to $73.60 on Friday on the New York Stock Exchange. Wall Street analysts had expected the drug to receive an expedited review.
The market value of the South San Francisco-based company has nearly doubled since May 19, when it announced the results of a large clinical trial that showed Avastin prolonged the lives of colon cancer patients by five months.
If the FDA approves it for sale, Avastin would be the first in a class of cancer drugs called angiogenesis inhibitors that work by pruning the vessels that supply blood to tumors. Without a steady blood supply, scientists say, tumors can’t grow.
Before the recent Avastin clinical trial, seven eagerly awaited angiogenesis inhibitors failed in late-stage human tests, and Genentech’s drug failed to work in breast cancer patients.
Avastin is a synthetic antibody that blocks a protein called VEGF, for 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.
Analysts predict that Avastin will become a blockbuster for Genentech, with annual drug sales as high as $2 billion. Colon cancer is the second-leading cause of cancer death in the U.S., next to lung cancer, and 147,500 new cases are diagnosed each year. Genentech is testing Avastin in other cancers.
Because Genentech invented the injectable treatment, it promises to be hugely profitable. John Sonnier of Prudential Securities said that every $100 million in Avastin sales would add 10 cents to Genentech’s annual per-share earnings. He estimated Avastin sales of $200 million in 2004, but some analysts forecast sales of $300 million.
Typically, the FDA reviews a marketing application for a drug after the data are assembled into a complete package, and that review process can take as long as a year. Fast-track status is given to experimental drugs for diseases with no adequate treatments; this allows Genentech to submit data as it becomes available.
The expedited process could cut the review time to six months, meaning Avastin could reach the market by year’s end or in early 2004.
The FDA’s action “recognizes the serious unmet medical need of patients with metastatic colorectal cancer and the potential of Avastin to affect this disease,” Genentech Chief Medical Officer Susan Desmond-Hellman said in a statement.
