WASHINGTON -- The Food and Drug Administration (FDA) announced today that it has revoked its approval of Avastin for metastatic breast cancer after concluding that the drug "has not been shown to be safe and effective for that use." The drug will remain an approved treatment for certain types of colon, lung, kidney and brain cancer. In June, an expert panel recommended that Avastin be withdrawn because there was no group of women with metastatic breast cancer who appeared to benefit from the drug, which can have harmful side effects. J. Leonard (Len) Lichtenfeld, M.D., deputy chief medical officer of the American Cancer Society, has commented on the decision on his widely read blog. Below are some of his comments: "This announcement culminates a highly watched process where the FDA determined that although it had granted accelerated approval for the use of this drug in treating breast cancer, subsequent studies did not demonstrate in any group of women that Avastin actually helped patients in any meaningful way, while causing significant harms -- including death. As difficult as this decision has been for the FDA, it is even more difficult for women who believe that Avastin has saved their lives. "The full impact of this decision is difficult to determine at this time. This decision will obviously lead insurance companies to review their payment policies regarding Avastin in breast cancer. Other experts have made their opinions known that in their experience Avastin has proven beneficial for breast cancer patients. Whether those opinions will provide sufficient reason for insurers and government programs such as Medicare and Medicaid to pay for this treatment remains unknown. At the least, we would hope that insurers will continue to cover treatment with Avastin in those women with metastatic breast cancer who are currently on the drug and who are showing a benefit from its use. "Ultimately, as noted by the Commissioner, this was a difficult decision to make, but one that had to be made based on the science. "As we move forward in the era of targeted therapies, there are bound to be more situations where the expectations of scientists, doctors, and patients may not be borne out with further investigation. We can all hope for success, but when success is not confirmed by the science we must be willing to reconsider whether our hopes were in fact realities. That is neither simple nor easy, especially when dealing with human life. But it is a principle to which we must adhere if we are to be honest with ourselves, our patients, and those we serve." ACS CAN, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, supports evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem. ACS CAN works to encourage elected officials and candidates to make cancer a top national priority. ACS CAN gives ordinary people extraordinary power to fight cancer with the training and tools they need to make their voices heard. For more information, visit www.fightcancer.org. FOR MORE INFORMATION, CONTACT: Steven Weiss or Alissa Havens American Cancer Society Cancer Action Network Phone: (202) 661-5711 or (202) 661-5772 Email: [email protected] or [email protected]