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FDA revokes indication for bevacizumab in metastatic breast cancer
Agency says risk for potentially life-threatening adverse events is too great.
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Saying that the available evidence does not show the drug to be safe or effective, the U.S. Food and Drug Administration today announced it is revoking its approval of bevacizumab for patients with metastatic breast cancer.
The FDA voted to remove the indication for use of bevacizumab (Avastin, Genentech) for first-line treatment of HER2-negative metastatic breast cancer in combination with paclitaxel following 2 days of hearings in June, but the final decision was up to FDA Commissioner Margaret A. Hamburg, MD.
“After reviewing the available studies, it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks,” she said in a press release. “Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”
Bevacizumab is still approved for colon, lung and kidney cancers and glioblastoma multiforme.
Bhuvaneswari Ramaswamy, MD, breast medical oncologist at the Ohio State University Comprehensive Cancer Center, is currently treating patients with bevacizumab on a clinical trial. She still sees promise in the drug, but she told HemOnc Today the FDA made the right decision in light of the current evidence.
“I certainly hope it doesn’t become a dead drug. My hope is that this drug will be pursued in a clinical trial setting,” she said. “There is a certain portion of patients who clearly seem to benefit from this drug. That benefit gets diluted when we try to treat all stage 4 breast cancer patients. We need to identify predictive biomarkers to find those patients who will benefit.”
FDA granted accelerated approval in 2008 based on the strength of results from the E2100 trial that showed bevacizumab treatment led to a 5.5-month improvement in PFS. However, the drug was associated with serious cardiotoxicity and the development of perforations in the nose, stomach and intestines, and the company was ordered to produce further results showing a survival benefit for the drug.
Two subsequent studies, AVADO and RIBBON1, submitted to FDA showed only a slight effect on tumor growth without demonstrating that patients lived any longer or had a better quality of life compared with standard chemotherapy.
The Oncologic Drugs Advisory Committee voted in July 2010 to remove the indication and FDA notified the company in January that the agency was revoking the indication.
At the time, Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said the agency could not support use of bevacizumab after reviewing results from four independent studies.
“We are disappointed with the outcome. 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,” Hal Barron, MD, Genentech’s chief medical officer and head of global product development, said in a prepared statement. “Despite today's action, we will start a new phase 3 study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin.” – by Jason Harris
Disclosure: Dr. Ramaswamy reports no relevant financial disclosures.
Earn CME this spring at the HemOnc Today Breast Cancer Review & Perspective meeting to be held March 23-24, 2012 at the Hilton San Diego Bayfront. See details at HemOncTodayBreastCancer.com.
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I am disappointed as a cancer doctor by the decision of the FDA to withdraw approval for Avastin in the metastatic setting, as I view it as taking away a weapon that was potentially useful. Nonetheless, I accept that we have been unable to define which patients for whom this drug may have a role. I also accept that the drug has shown both very modest benefit and hard-to-manage, and at times life-threatening, toxicities. In sum, the decision was not unexpected and is difficult to rebut.
Ellis Levine, MD
Associate Professor of
Medicine with Roswell Park Cancer Institute, Buffalo, NY
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