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Dr. Kim Mulvihill ReportingEnrollment in a trial involving a blockbuster cancer drug is temporarily halted. The reason: Several unexplained deaths, some of which occurred in younger patients.
Avastin is the medical world's equivalent of a smart bomb. It targets cancer and leaves healthy cells alone. The drug zeros in on a tumor and cuts off its ability to make the blood vessels that allow it to grow.
The drug, made by Genentech, has extended the lives of lung, breast and colon cancer patients.
However, an independent safety review board has temporarily halted enrollment in a trial involving Avastin in colon cancer patients. In one part of the trial, there were several unexplained deaths among patients.
Those patients were using a combination of Avastin with a chemotherapy drug known as Xelox.
Sue Hellman, M.D./ Genentech: "What we do know is that Avastin combines very well with many chemotherapies. But what we don't know yet is whether it will be safe and effective wich each other and every chemotherapy we try."
Dr. Sue Hellman is president of product development at Genentech. She says patients already enrolled will continue on the study. The data safety monitoring board will review 60 days worth of safety data.
Sue Hellman, M.D./ Genentech: "After 60 days, how will things look? How are patients doing? Will there be more adverse events? Will patients be okay?"
Scientists don't know whether there is a problem with this combination of drugs.
John Ward, M.D./ Oncologist: "The toxicity may be great. The juice may not be worth the squeeze. So ultimately that's why you need a trial to compare a new idea to a standard therapy."
But they do know for the first time in more than 70 years, annual cancer deaths in the United States have declined.. in part due to better treatment which includes targeted therapies.
John Ward, M.D./ Oncologist: "In colon cancer in the past five years there have been four new drugs that have all improved the outcome of patients with colon cancer."
This is why clinical trials are so important, to evaluate drugs in a controlled fashion to be certain what the benefits and risks are.
