FDA: Risks Outweigh Potential Benefits of Drug
The drug Avastin should no longer be approved to fight breast cancer, the U.S. Food and Drug Administration concluded Thursday. The agency cited studies that have shown the drug doesn't prolong survival or slow the disease's progression and that it carries substantial risks, including severe high blood pressure, bleeding and hemorrhaging, and heart attack or heart failure. The agency's announcement does not mean it will remove Avastin from the market. For now, the drug continues to hold its approved status for breast cancer, pending an appeal process. Moreover, the FDA has not proposed revoking the drug's approvals for cancers of the colon, kidneys, brain, and lungs. Oncologists treating breast-cancer patients with Avastin should use their judgment in deciding whether to continue treatment or use other options, according to the FDA. Avastin's maker, Genentech, which received approval to market the treatment for breast cancer in 2008, indicated on Thursday that it would exercise the right to a hearing to contest the FDA's proposed revocation. The FDA's announcement follows the advice of an independent committee, which, in a 12-1 vote last July, recommended the FDA revoke the approval.
While it's difficult to know whether a certain medication will help a breast-cancer patient, aspirin may be an effective therapy for survivors to cut risk of the disease's recurrence, U.S. News's Bernadine Healy reported in February.
"Has it spread?" "Am I going to die?" These are the heart-sinking questions that invariably run through the minds of women who have been told that they have breast cancer. They courageously take on surgery, long and arduous chemotherapy, and radiation treatments, hoping to fend off the fate of the 40,000 women whose breast cancer will take a deadly turn this year, reappearing and relentlessly spreading throughout their body.
The report released in February from the Nurses' Health Study, in a rather understated way, offers 2 million American women who have had breast cancer some vital and actionable information. Taking a single aspirin tablet—a baby aspirin or one adult pill—every other day can be lifesaving. (In fact, were these aspirin tablets a hot new biotech drug, we would be popping champagne right now.) The long-term, low-dose aspirin program was initiated a year or more after the cancer diagnosis as an add-on to treatment, not as a substitute for it, to control the fate of tumor cells silently left behind. For some women, this post-treatment phase is one in which the cancer has gone underground and not entirely disappeared. It can lead to unexpected recurrence with the cancer spreading sometimes 10 to 20 years after diagnosis. Scientists seem to have stumbled upon an easy way to cut that risk.
The study followed 4,164 breast cancer survivors over a period from 1976 to 2006, assessing in detail their use of aspirin. The women studied initially presented with tumors ranging from small early invasive cancers confined to the breast to more advanced ones that had spread into surrounding lymph nodes. Over more than three decades of follow-up, 400 women had a cancer recurrence with distant tumor spread, which had killed 341 of them by the time the study ended.
The power to spread is the power to kill, and what aspirin seems to be doing is interfering with that process. It was by coincidence, not by design, that almost half of the medically smart women in the NHS were diligently taking aspirin. The surprise finding: Those who made aspirin a regular habit, consuming low doses two to five times a week (mostly to help their hearts), were 71 percent less likely to have a deadly recurrence of their breast cancer compared to those who were taking little or no aspirin.
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