June 29, 2011 -- 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.
"I think we all wanted Avastin to succeed. These studies didn't bear out this hope," said Natalie Compagni-Portis, the panel's patient representative.
The decision of the FDA panel followed testimony by some patients who wanted to keep Avastin on the market while Genentech continues to study the drug.
Heraleen Broome, a breast cancer patient who credits Avastin with keeping her alive after failing chemotherapy eight years ago, said the drug should stay on the market despite the risks.
"Just because it doesn't work on some people it doesn't mean that everyone should be deprived," Broome said on MSNBC Wednesday.
FDA scientists, and ultimately, the expert panel reviewing scientific data, disagreed. Experts came to view the trial that initially showed Avastin's success as an anomaly. Later studies showed much less ability of Avastin to forestall cancer progression when combined with other drugs. And none reliably showed that Avastin helps breast cancer patients live longer.
"Now we've seen three subsequent trials that have all failed to confirm the magnitude of benefit," said Brent Logan, PhD, an associate professor of biostatistics at the Medical College of Wisconsin and a member of the FDA panel.
Genentech officials offered to compromise with the FDA. The company suggested confining Avastin to a narrow group of severely ill patients with certain genetic profiles as a way to keep the drug on the market while new studies are being performed.
"We are very disappointed by the committee's recommendation and hope the commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options," Hal Barron, MD, the company's chief medical officer, said in a statement following the meeting.
Genentech officials said the company was planning a new study of Avastin that would not be completed before 2016. If Hamburg decides to suspend Avastin's breast cancer approval, the drug could potentially come back on the market for breast cancer after the company reapplied with the FDA.