“After reviewing the available studies,” she continued, “it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will help them live longer or improve their quality of life.”
Medicare, which covers many women with breast cancer, has already said it would continue to cover the cost no matter what the F.D.A. decided. Medicare is obligated to pay for off-label use of cancer drugs that are listed in references known as compendia, such as the one published by the National Comprehensive Cancer Network, an organization of major cancer hospitals.
An initial clinical trial showed that Avastin, when combined with the drug paclitaxel, which is also known by the brand name Taxol, delayed the progression of disease by about five and a half months, compared to use of paclitaxel alone. However, the women who received Avastin in the study did not live significantly longer and they suffered more side effects.
Based on that data, the F.D.A.’s cancer drug advisory committee voted 5 to 4 against approval in December 2007. But two months later, the agency granted provisional approval.
In subsequent studies, in which Avastin was combined with different chemotherapy drugs, tumor growth was delayed by only one to three months. And Avastin did not prolong lives at all, nor did it improve quality of life.
In July 2010, the F.D.A.’s cancer drug advisory committee recommended 12 to 1 that the approval be revoked. The F.D.A. itself moved to do that in December of that year.
By ANDREW POLLACK
Published: November 18, 2011