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"There certainly are patients who benefit tremendously," said Boyce's oncologist, Dr. Melody Cobleigh of Rush University Medical Center. "We'll just be battling with the insurance companies."
"For those not fortunate enough to be on Medicare or an insurance plan that covers it, it's a death sentence," Christi Turnage of Madison, Miss., said of the FDA's decision. Her breast cancer had moved into her lungs before she began Avastin three years ago and the spreading stopped, but Turnage said her insurer is ending coverage and she will seek financial help from Genentech's access program.
Hamburg said that she considered those arguments but that scientifically there are no clues yet to identify who those rare Avastin responders would be -- putting a lot of people at risk in order for a few to get some as-yet-unknowable benefit. She urged Genentech to do that research, saying the FDA "absolutely" would reconsider if the company could find the right evidence.
Genentech, part of Swiss drugmaker Roche Group, pledged to begin that research.
"We are disappointed with the outcome," said company chief medical officer Dr. Hal Barron. "We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment in the United States."
The breast cancer organization Susan G. Komen for the Cure said that it respected the FDA's decision and that it was time for researchers to concentrate on finding so-called biomarkers that would tell which drug is right for which patient.
"Each type of cancer is very different from another in important ways, and in the end it's no surprise that Avastin's effectiveness may not be equivalent against all types of cancer," said Dr. Neal Meropol of University Hospitals Case Medical Center in Cleveland, who has long used Avastin for colon cancer.
Copyright 2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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