FDA ADVISORY COMMITTEE TO REVIEW AVASTIN SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR METASTATIC BREAST CANCER

September 13, 2007 - Genentech, Inc. stated today that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's supplemental Biologics License Application (sBLA) for Avastin® (bevacizumab), in combination with paclitaxel chemotherapy, for patients who have not received chemotherapy for their locally recurrent or metastatic breast cancer. The company was notified that the ODAC meeting would occur in December 2007 and the FDA action date is February 23, 2008. The sBLA is based on a trial known as E2100.

"We are pleased that the independently reviewed E2100 data support the investigators' initial assessment and demonstrate a significant clinical benefit for advanced breast cancer patients who participated in the study," said Hal Barron, M.D., senior vice president, Development and chief medical officer.

E2100 was a pivotal Phase III multicenter, randomized, and controlled clinical trial that enrolled 722 patients with previously untreated, locally recurrent or metastatic breast cancer. It was sponsored by the National Cancer Institute under a Cooperative Research and Development Agreement, and was conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG).

In May 2006, Genentech submitted an sBLA for Avastin based on the investigator-assessed results of E2100. The company resubmitted the sBLA in August 2007 after receiving a Complete Response Letter from the FDA requesting additional information from the trial, including an independent, blinded review of patient scans for progression-free survival (PFS), the primary endpoint. With a hazard ratio of 0.48 for PFS, the independent review showed a similar magnitude of benefit to the data presented by ECOG at the American Society of Clinical Oncology annual meeting in 2005. Overall survival, a secondary endpoint of the trial, was improved although the improvement was not statistically significant. No new safety signals related to Avastin were observed.