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Pancreas Cancer News and Archives | |
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Genentech Wins FDA Approval for Colon Cancer Drug
Avastin was approved for use in combination with chemotherapy as a first-line treatment for colon cancer in patients whose disease has spread to other parts of the body. The approval for Avastin, which came a month earlier than the Food and Drug Administration (news - web sites) decision deadline, marks the first for a drug that works via the tumor-starving mechanism known as anti-angiogenesis. "It is a big step forward for patients, and it's a huge step forward for Genentech," said Jason Kantor, an analyst of WR Hambrecht. Genentech officials said late on Thursday that they had already begun shipping Avastin, and that it could be available to patients as early as next week. "To see the first shipment go out today is the end of a long effort, it's just terrific. This is what we live for," Susan Hellman, Genentech's chief medical officer, told analysts on a conference call. The company said Avastin, which is administered every two weeks, will cost $2,200 per dose, or $4,400 per patient per month. Analysts estimate global sales of Avastin to reach between $1.6 billion and $1.8 billion a year by 2008. "What is most remarkable is its potential for use in many other tumor types -- other diseases such as renal cancer, pancreatic cancer, even breast cancer, lymphoma, bladder cancer, prostate cancer," said Sanford Bernstein analyst Geoff Porges. The company said it expects to complete patient enrollment this year for clinical trials of Avastin for non-small cell lung cancer and first line breast cancer. Studies in a broad range of other tumor types also are planned, Genentech said. The drug's approval has been highly anticipated since an 800-patient trial showed that previously untreated patients given a combination of the biotech drug and chemotherapy lived an average of 20.3 months, compared with 15.6 months for patients treated with chemotherapy alone. "Seeing a survival advantage of this magnitude is unusual. This is actually very exciting," said Dr. Patricia Keegan, an FDA official who oversaw the Avastin review. "In every subset analysis of the trial, every patient regardless of gender, age, extent of disease -- all of them responded," added Keegan. "All the patients derived benefits from the addition of Avastin." Genentech shares rose 45 percent last May 19 when it first said the drug extended life longer than expected. Shares of the South San Francisco-based company closed up $7.02, or 7.3 percent, at $103.10 on the New York Stock Exchange (news - web sites) after the news of the FDA approval -- their highest point since a stock split in October 2000. Patrick Flanigan, an analyst for Adams, Harkness & Hill, said the steep share price was justified. "Genentech definitely has the strongest fundamentals in biotech," he said of the company in which Swiss drug maker Roche Holding AG holds a majority stake. He noted that the company has in recent months delivered three drugs with potential annual revenue of more than $500 million. While Avastin approval was widely expected, analysts said it was an extremely positive development that it was approved for use in combination with a wider variety of chemotherapy regimens than they had expected. "The broad label is very favorable because it minimizes any type of (insurance) reimbursement risk that could arise from the off-label use of Avastin," Flanigan said. "Clearly we are very pleased with the scope of the label," said Ian Clark, Genentech's vice president of bio-oncology. He said they expect insurance reimbursement of about 95 percent of the cost of the drug. Earlier this month, the FDA approved ImClone Systems Inc's Erbitux as a colon cancer treatment in patients for whom chemotherapy has failed. That gives Avastin an advantage as a first-line treatment that doctors would turn to before Erbitux, which uses a different mechanism, becomes an option. ImClone shares fell 1.5 percent to $42.80. Hellman said Avastin will be tested in combination with a wide variety of cancer treatments, including Erbitux. "We think the day may come when we can treat patients without chemotherapy," she said. Bernstein analyst Porges said that while several companies are working to develop similar cancer therapies, Genentech will have a significant head start with Avastin. "They have three years of very clear running in the market, after that it's going to get crowded," he said. (Additional reporting by Jed Seltzer)
SOURCE: Reuters |
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