Genentech Receives FDA Letter for More Data on Proposed Expanded Use of Avastin

Genentech Receives FDA Letter for More Data on Proposed Expanded Use of Avastin SAN FRANCISCO (AP) -- Drug maker Genentech Inc. said Monday the Food and Drug Administration had sent it a complete response letter asking for more safety and efficacy information on a new application for its metastatic breast cancer treatment Avastin.
The company had asked the FDA to approve Avastin's use as a first-line therapy in conjunction with chemotherapy for metatastic breast cancer. The request means the company will have to recollect information from study sites.

The study was sponsored by the National Cancer Institute and conducted by a network of researchers led by the Eastern Cooperative Oncology Group. Genentech had submitted interim data from the trial in May.

Genentech anticipates resubmitting the data by the middle of 2007. The FDA will start a new six-month review once the data is submitted, the company said.

Avastin was approved in 2004 for the treatment of metastatic colorectal cancer. The company has been testing Avastin as a treatment for several other types of cancer. The company halted a trial testing its effectiveness on pancreatic cancer in June, after early data showed it was not significantly effective.

Shares of Genentech fell $3.16, or 3.9 percent, to $78.91 on the New York Stock Exchange in morning trading. The stock has traded between $75.58 and $100.20 over the last 52 weeks.

Metastatic breast cancer means that the cancer is relocating to other parts of the body. Usually, breast cancer cells migrate to bone and liver making it very hard to treat. Bone metastases are very nasty since radiation cannot fully penetrate bone.

Avastin is an anti-angiogenic drug that stops tumors from making their own networks of blood vessels to supply it. Avastin is a monoclonal antibody directed to bind to vascular endothelial growth factor. Basically, it binds to the signal that tells cells to make new blood vessels. Without an adequate blood supply, a tumor that wants to grow rapidly, needs a big, fresh blood supply. Without that, it shrinks and dies.

Genentech trades under the symbol DNA.