A panel of cancer experts ruled Wednesday that Avastin - the world's best-selling cancer drug, developed by Genentech in South San Francisco - should no longer be used in breast cancer patients because of concerns the medicine didn't work as well in follow-up studies and may cause deadly bleeding.Outside advisers to the Food and Drug Administration voted 6-0 against Avastin's use in breast cancer at a first-of-its-kind hearing in Silver Spring, Md. Their recommendations will be sent to FDA Commissioner Margaret Hamburg, who will make the final ruling on an unspecified date. Avastin will remain on the market because it's approved for four other types of tumors.
The decision capped two days of testimony from patients urging the panel to continue access while FDA scientists argued the drug is too dangerous. A final ruling is at least weeks away while the agency takes comments from the public through July 28. Doctors can prescribe Avastin "off label" in breast cancer even if approval is withdrawn, though insurers may no longer pay the $8,100-a-month price tag.
"There are just so many questions here and the agency has to look at protecting a larger number of patients," said panel member Ralph Freedman, a clinical professor at the University of Texas M.D. Anderson Cancer Center in Houston.
The panel took a little more than an hour for its deliberations, less than half of the time allotted by the FDA. The advisers also voted unanimously that Avastin didn't have benefits in breast cancer and that its risks weren't justified.
Avastin also is used to treat lung, kidney, colon and brain cancer. Approval for those uses won't be affected by Wednesday's recommendation. Global sales last year were $6.22 billion, or 14 percent of revenue for Roche Holdings AG, Genentech's parent company based in Basel, Switzerland.Read More
An FDA panel has recommended that the drug Avastin no longer be sold as a treatment for breast cancer.
The unanimous recommendation came after experts concluded that Avastin offers breast cancer patients no substantial benefits but at the same time carries substantial risks.
The panel's decision does not affect other uses for which Avastin is approved, including advanced non-small-cell lung cancer, metastatic colorectal cancer, metastatic renal cell carcinoma, and glioblastoma brain tumors.
But if the FDA follows the panel's recommendation, it would be a setback for the treatment of advanced metastatic breast cancer.
The panel's decision was a blow to California-based Genentech, which manufacturers Avastin, known generically as bevacizumab. The company secured fast-track approval for the drug in 2008 after early studies showed it slowed progression of a severe form of breast cancer by an average of 5.5 months.
But later studies failed to back up those earlier findings. The FDA panel concluded that overall, Avastin does not help breast cancer patients live substantially longer or enjoy better quality of life with the disease. The drug carries significant, sometimes fatal, cardiovascular and other side effects.
The recommendation could lead FDA Commissioner Margaret Hamburg, MD, to suspend marketing of Avastin for the treatment of breast cancer.
"She will make a decision based on all this information," said Karen Midthun, MD, who directs FDA's Center for Biologics Evaluation and Research. "I cannot tell you at this point when the decision will be finalized and issued," Midthun said, as she ended a two-day meeting on Avastin. Read More
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