Avastin Fails in Colon Cancer TrialApr 23, 2009 | Parker Waichman LLP
Avastin has not been shown to reduce the recurrence of colon cancer, according to the results of a recent clinical trial. It's just the latest bit of bad news regarding the cancer drug, which has been the subject of numerous safety concerns.
According to The Wall Street Journal, the clinical trial involved 2,700 patients who underwent surgery to remove their cancer, and were then divided into two groups. One group received chemotherapy alone for six months, and the other chemotherapy plus Avastin for six months, followed by an additional six months of Avastin alone. In the Avastin group, the drug failed to meet its primary aim of significantly lowering the risk of the cancer returning.
Roche did not release the study's data. According to the Journal, the data will be presented the American Society of Clinical Oncology conference, which begins next month.
Roche, which recently acquired Avastin's maker Genentech, had been hoping to expand its approved uses to include early-stage cancer, a move that would boost the drug's sales significantly, the Journal said.
Avastin was the first approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor. Avastin was approved by the Food & Drug Administration (FDA) in 2004 to treat metastatic colon cancer, and in 2006, the agency approved it as a treatment for non-small cell lung cancer. Last year, the FDA also approved Avastin as a metastatic breast cancer treatment. Last month, an FDA advisory panel recommended that Avastin be approved to treat glioblastoma multiforme, an incurable brain cancer.
Avastin approvals have come with controversy, as the drug has been the subject of various safety concerns. When the FDA approved Avastin for breast cancer patients last year, it did so against the recommendation of its own advisory panel. In late 2007, the panel had voted 5-4 to recommend that the agency reject Genentech’s application to expand the approved uses of the drug to include advanced breast cancer. The FDA advisory panel vote came after agency staffers posted documents on the FDA website noting that while Avastin did extend the period prior to patients’ breast cancer becoming worse, treatment with the drug did not markedly increase survival time. The FDA documents also pointed out that Avastin caused serious side effects, including cardiovascular problems, bowel perforations, and a few deaths. The FDA staff said that those side effects included several patient deaths that were “probably or definitely” due to Avastin.
Last June, researchers at Stony Brook University Cancer Center in New York released a study showing that about 12 percent of people who took Avastin developed blood clots in the veins, a rate that’s about 30 percent higher than among other cancer patients who are not taking it. These types of blood clots put patients at a higher risk of death, because they can travel to the lungs. Clots are already a common problem faced by cancer patients.
In December, Genentech also reported that some Avastin patients had experienced eye inflammation when it was used off-label to treat an eye condition.