Avastin’s approval for breast cancer could be revoked; FDA is pondering
Whether the cancer drug Avastin should be revoked as a treatment for advanced breast cancer is the subject of both passion and debate. Some breast cancer patients and doctors desperately want the drug to remain available; the FDA is holding hearings on the matter Tuesday and Wednesday.
The drug’s maker, Genentech, seeks to convince an FDA panel that Avastin’s benefits outweigh its risks. The FDA isn’t yet convinced. The back-and-forth on the drug’s approval has been a rare challenge to the FDA’s authority to judge the effectiveness and safety of a drug, as a CNN article notes.
But about the drug… Avastin, or bevacizumab, is an injected medication thought to slow cancer by choking off the blood vessels that feed tumor growth. The drug blocks a protein important for forming such vessels, according to the FDA.
Not surprisingly, many of the drug’s side effects affect the blood—according to drugs.com, sometimes leading to wounds that won’t heal, blood in the urine and stools, and easy bruising.
PubMed Health explains the side effects in women who took Avastin for breast cancer:
“These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.”
The drug is approved for colon, lung, kidney and brain cancers, but was only approved to treat metastatic breast cancer in 2008 under an accelerated approval contingent on further research. After clinical trials showed no apparent benefit from the drug for treating breast cancer, an FDA panel voted last year to withdraw the drug.
Though the emotional pleas to keep the drug approved for this use come from breast cancer survivors, even Karuna Jaggar, the executive director of the advocacy group Breast Cancer Action told MarketPlace Morning Report:
“The whole point of a provisional approval is that it can be rolled back, if it turns out the drug does not perform as first expected.”
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