The US Food and Drug Administration approved Genentech's Avastin for breast cancer
Avastin is approved as a treatment for lung and colon cancer. The approval is based on a phase III study (E2100) which showed that for patients with metastatic breast cancer the addition of Avastin to paclitaxel compared to paclitaxel alone doubled the chance of being alive without the disease advancing ("progression-free survival"). In Europe Avastin received full approval for the treatment of metastatic breast cancer in March 2007.
Avastin was approved in advanced breast cancer under the US FDA's accelerated approval programme, which allows the US FDA to approve products for cancer or other life-threatening diseases based on initial positive clinical data.
Genentech has shared with the US FDA a summary of the results from a second positive phase III trial (AVADO = Avastin plus docetaxel chemotherapy vs docetaxel alone), and is expecting results from a third phase III trial (RIBBON-1) in first-line metastatic breast cancer in late 2008.
Avastin is the first anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival benefit for colorectal, lung, breast and, renal cell cancer patients.