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There's more trouble for Avastin (bevacizumab). On April 22, 2009 the US manufacturer, Genentech, Inc. announced that the drug had failed to prevent colon cancer in a large National Cancer Institute (NCI)-sponsored clinical trial. A successful trial would have been a big boost for Genentech, and for its Swiss parent company, Roche, which acquired Genentech in March.
Genentech, however, continues to sound optimistic about Avastin. "Our initial review of the data leads us to continue to believe Avastin may be active in patients with early-stage colon cancer," Hal Barron, the company's chief medical officer, said in a statement. The data will be presented at the late May meeting of the American Society for Clinical Oncology (ASCO). All the company is saying for now is that Avastin did not "meet its endpoint," i.e., did not reduce the risk of cancer returning by the targeted amount.
Avastin had sales of $2.7 billion in the United States alone last year. It is currently approved for late-stage colon, breast and lung cancers. According to the New York Times, "in that use, trials have shown the drug can prolong life by up to a few months." That was true in colon cancer clinical trials. (The drug's results in the community setting remain unknown.) For breast cancer, however, the drug does not actually improve survival. In fact, in 2007, the FDA's Oncology Drug Advisory Committee (ODAC) recommended against approval, but was overruled by the director of the FDA. In the case of brain cancer (glioblastoma multiforme), ODAC recommended approval in early April 2009, but again without proof of increased survival.
The new early-stage colon cancer trial was an attempt to use the drug earlier in the course of the disease, right after surgery had been performed to remove the tumor. Presumably, the drug would prevent cancer from recurring, in effect curing the patient of the disease. To test this hypothesis, about 2,700 patients received either six months of standard chemotherapy or six months of the same chemotherapy plus a year of Avastin. The study then measured how many patients were alive and free of cancer over time. Apparently the results were not significantly different, although the oncology world eagerly awaits the ASCO meeting disclosures, which will be scrutinized for any sign of benefit from the drug. Not one to be discouraged, Roche is running another trial of Avastin, this one for early-stage colon cancer. Results of that trial are expected in 2010. Roche and Genentech are also testing the drug for use in early-stage breast and lung cancers. A lot of money is riding on this determination since Genentech has said that Avastin sales could quadruple - to $10 billion by 2015 - if it could get the drug approved for early-stage colon, lung and breast cancer. Unfortunately, the drug does not seem to be cooperating in that effort.
--Ralph W. Moss, Ph.D.
References:
Andrew Pollack. Avastin falls short in colon cancer trial. New York Times, April 22, 2009.
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PHONE CONSULTATIONS
Ralph Moss does phone consultations for clients who have previously ordered one of our comprehensive Moss Reports on their cancer. Here is a comment of one of our recent phone consultations:
"I was diagnosed with invasion ductal breast cancer in October 2008 on the basis of a biopsy. For that procedure and over the next few months, I spent about $10,000 out of pocket for diagnostic procedures to determine what kind of treatment I would have. (These were just the costs that my insurer didn't cover.) After spending all that money and consulting with seven different doctors, I was left with no certainty of what to do next. All the information I got was conflicting. The process was dehumanizing and exhausting.
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WHERE TO GO? - CAM RESOURCES IN SELECTED METROPOLITAN REGIONS
The Where To Go? series continues to attract favorable reviews from readers. Already available are Where to Go? - Germany ("Complementary And Alternative (CAM) Cancer Treatments In Germany"), Where To Go? - Houston, Where To Go? - Philadelphia, Where To Go? - Chicago and Where To Go? - Boston. These reports offer useful information on regional availability of complementary and alternative medicine (CAM).
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CANCER DECISIONS© AND CURRENT TOPICS© REPORTS
Reports in our Cancer Decisions© series are designed to provide readers with the detailed information they need in order to make difficult treatment decisions. Currently available are:
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