FDA Rescinds Approval of Avastin for Breast Cancer Treatment
A drug used to treat metastatic breast cancer has had its approval revoked by the Food and Drug Administration (FDA) after concerns had been raised regarding lack of efficacy and dangerous side effects. Avastin (bevacizumab) is a drug which had been used to treat several different forms of cancer, including colorectal, lung, kidney and glioblastoma (a type of brain cancer). Up until today, Avastin belongs to a newer class of cancer drug which blocks a tumor's ability to grow blood vessels, and therefore, spread further from the primary site. It had been hoped that Avastin would slow the growth of tumors in patients whose cancers had already spread, thus prolonging survival and quality of life.
Up until today, Avastin had FDA approval in the treatment of metastatic breast cancer in combination with another chemotherapy drug, paclitaxel, in patients with HER-2 negative type breast tumors. It had initially been thought to help prolong the survival of women with advanced breast tumors. In such cases. few treatment options exist; the arrival of a new therapy like Avastin, which aimed to prolong the survival of these patients, was welcomed.
However, Avastin is a drug with many side effects, some of them quite serious, including severe high blood pressure, heart attack/heart failure, internal bleeding and hemorrhaging, and perforations of the nose, stomach and intestines. The chair of the FDA felt that the severity of the side effects, in combination with a lack of data showing it reduced tumor growth, was reason to withdraw approval of the drug for the treatment of metastatic breast cancer. “This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use,” FDA Commissioner Dr. Margaret Hamburg said. “After reviewing the available studies 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 either help them live longer or improve their quality of life.Continued on the next page