Proponents of the cancer drug Avastin were dealt a blow this week when new data regarding the drug’s effectiveness in battling ovarian cancer fell short of expectations.
Back in November, the Food and Drug Administration made the controversial decision to pull Avastin for breast cancer treatment, and Commissioner Margaret Hamburg indicated at the time that “there [was] no benefit to breast cancer patients that would justify [Avastin's] risks.” The decision was not without controversy, and one advisory panel member, Dr. Mikkael Sekeres, told NPR that he’d “struggled with [the FDA's] decision on whether to recommend removing the breast cancer label from Avastin,” but that the panel eventually came to the conclusion that “the significant risks associated with the drug far outweighed the lack of benefit.”
Those significant risks include increased possibility of blood clots as well as “heart attack, heart failure and severe bleeding.” The initial reason did not mandate doctors not prescribe Avastin for breast cancer, merely that the use of Avastin for breast cancer would be considered “off label”- which is similar to when doctors prescribe birth control pills to treat facial acne. While the decision allows patients access to the drug, it often means insurance refuses to cover the medication for treatment of breast cancer- making treatment with Avastin (which can top $100,000 a year) unaffordable to many patients who wish to use the drug to prolong their lives.
The two most recent studies found that while Avastin can add a few months to survival rates, the drug’s side effects did not justify its use. Ultimately, while Avastin won approval for treatment of advanced ovarian cancer in Europe last week, a spokeswoman for maker Genentech says that after talking with the FDA, the company does not believe “data will support approval” in the US.