FDA withdraws approval of Avastin (Genentech) for Breast Cancer patients

The FDA has revoked the agency�s accelerated approval of the Breast Cancer indication for Avastin (bevacizumab), from Genentech. According to the FDA, Avastin has not shown benefit for delaying the growth of tumours in patients with metastatic Breast Cancer and thus cannot justify its costs and serious and potentially life-threatening risks. Nor is there evidence that use of Avastin helps women with Breast Cancer live longer or improves their quality of life. The FDA's decision involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic Breast Cancer known as HER2 negative. This indication must now be removed from Avastin's product labeling. Following accelerated approval of Avastin for Breast Cancer in 2008, Genentech completed two additional clinical trials and submitted the data to the FDA. These showed only a small effect on tumour growth without evidence that patients lived any longer or had a better quality of life. Avastin will remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).