Cancer Drug Avastin Flunks Clinical Trial

Avastin, the Roche-Genentech cancer drug, has failed in a clinical trial designed to test the drug’s ability to substantially prolong the lives of people with early-stage cancer colon cancer, officials said.

Avastin was developed by Genentech, the U.S. drug maker Swiss drug company Roche just paid $46.8 billion to take over. The drug’s poor showing in a recently completed trial of its effectiveness in fighting colon cancer is a blow to Avastin, which is a top seller for treatment of breast, lung, and colorectal cancer, having earned U.S. sales of $2.69 billion in 2008.

Roche and Genentech have said they may seek to further expand Avantis for treatment of certain brain, kidney and ovarian cancers.

Study of Post-Surgery Colon Cancer Patients

About 2,700 colon cancer patients who had undergone surgery and chemotherapy were part of the newly released clinical study. Some were given Avastin and some were not, and researchers found that Avastin did not substantially lower the risk of the cancer returning.

The study examined the effectiveness of chemotherapy combined with Avastin on patients with Stage II or III colon cancer. It was conducted by the National Surgical Adjuvant Breast and Bowel Project. The study’s findings will be presented at a future annual meeting of the American Society of Clinical Oncology.

FDA Approves Broader Uses of Avastin

The Food and Drug Administration approved Avastin in 2004 to treat metastatic colon cancer and in 2006 to treat certain types of lung cancer.

In 2008, the FDA further approved Avastin to treat metastatic breast cancer and most recently, a panel of experts who advise the FDA on new drugs and new drug approvals recommended that Avastin be approved to treat an incurable form of brain brain cancer called glioblastoma multiforme.

Serious Side Effects of Avastin

The use of Avastin carries increased risks of some serious side effects. Cardiovascular problems, bowel perforations, and life-threatening blood clotting has been linked to the drug. One recent study found that as many as 12 percent of people on Avastin developed blood clots in their veins, which may detach and leave patients at increased risks of stroke and other deadly complications. The rate of blood clots in cancer patients taking Avastin was as much as 30 percent higher than patients not taking the drug.

Patients taking Avastin for cancer treatments also have reported suffering from eye inflammation when used unapproved to treat an eye condition.

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