Drug manufacturer and patients fight to keep treatment available via Google Images
Several cancer survivors gathered outside a Food and Drug Administration office building in Silver Spring, Maryland where a panel of six experts was getting ready two days of discussion and a vote on the fate of Avastin, the drug that may have saved their lives.
In July 2010, an advisory panel voted 12-1 to withdraw the specific approval of Avastin as a therapy to treat advanced, or metastatic, breast cancer (cancer that has spread from its original site) because four clinical studies showed that the drug did not make patients live longer and because of dangerous side effects, including increased risks of internal bleeding and high blood pressure. In December, the FDA’s Center for Drug Evaluation and Research (CDER) proposed that Avastin’s approval to treat advanced breast cancer be taken away.
Before FDA Commissioner Margaret Hamburg could make the recommendation final, Avastin’s maker, Genentech, filed an appeal. According to Charlotte Arnold, a Genentech spokeswoman, the number of patients receiving the drug dropped from about 60 percent of new cases to only 20-25 percent since the original ruling. Metastatic breast cancer is diagnosed in approximately 29,000 women in the U.S. every year.
Avastin (which works by restricting blood flow to tumors) was first approved as a therapy for cancer in 2004. Since then, it has been approved to treat certain cancers of the lung, kidney, colon and brain. In 2008, it was given provisional approval to treat breast cancer, on the condition that Genentech continue research, and report the findings. When those results became public last year, the results were, in general, not very promising. Some cancer specialists (and patients) say that hidden in the larger group are a number of “super-responders” who show dramatic improvement. At the July hearing, some panel members shared their hope that Genentech would conduct research to see if it can identify the patients most likely to respond.
But Dr. Joanne Mortimer, a breast cancer specialist in California who was on the panel and voted to reverse the approval, said the overall ratio of risk to benefits was too extreme. Karuna Jaggar, executive director of Breast Cancer Action, an advocacy group based in San Francisco, also says CDER made the right decision. “We cannot settle for hope. We need treatments that perform, that actually improve overall survival and which improve the quality of life for women. Avastin has not been demonstrated to do that,” she said.
While some see the science as cut and dry, others fear the panel’s vote may have been influenced by the new health care law and Avastin’s imposing price tag, which runs as high as $88,000 for a full year of treatment. Sen. David Vitter, R-Louisiana, wrote to the FDA complaining that “the (FDA advisory) committee’s concerns appear to have been based on cost-effectiveness.” According to FDA policy and officials the agency does not take cost into account when deciding drug approvals.
Since Avastin is approved for other uses, doctors would still be allowed to prescribe it, regardles of the FDA’s final decision, but many insurance companies would likely be unlikely to pay nearly $90,000 for a treatment not approved by the FDA.
The accelerated approval program (established in 1992 as a way of shortening the wait for patients to receive new, promising treatments) has produced four drugs in the world of cancer therapy. All four acclerated approvals have since been withdrawn by the companies who make them, according to Erica Goode, an FDA spokeswoman. In each case, the drug company accepted evidence that early results were no longer as promising as they had first seemed. Genentech did not.
Arnold says that no other medicine has been shown to work better against a certain type of breast cancer to date, and the panel should leave Avastin available, at least while research continues. “Ultimately, maintaining accelerated approval while we conduct a new trial is allowed by law, supported by science and is in the best interest of the patients who may need this medicine…The company will present its case based on the scientific data,” she wrote in an e-mail.
Of the six voting members, five were on the panel that rejected Avastin last summer and voted to remove the breast cancer indication. Whatever the vote, the final decision is expected to take at least several weeks, and will ultimately rest in the hands of Commissioner Hamburg.
According to Karen Riley, another FDA spokeswoman, it is not the first time a company has appealed an FDA decision, but neither she nor John Jenkins (the director of the FDA’s Office of New Drugs) could immediately recall another example.
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