Description Avastin® (bevacizumab) is a recombinant humanized antibody to vascular endothelial growth factor (VEGF). Avastin is designed to bind to and inhibit VEGF, a protein that plays a critical role in tumor angiogenesis (the formation of new blood vessels to the tumor).

Development Status In the third quarter of 2008, we submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the potential treatment of first-line metastatic renal cell carcinoma. This submission has a Prescription Drug User Fee Act (PDUFA) date of August 1, 2009. In the fourth quarter of 2008, we submitted an sBLA to the FDA for the potential treatment of previously treated glioblastoma (an aggressive type of brain cancer). On March 31, 2009, the FDA Oncologic Drugs Advisory Committee (ODAC) voted unanimously that the response seen with Avastin in patients with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit. This submission was granted Priority Review and has a PDUFA date of May 5, 2009.

In the second half of 2009, we plan to submit data from two clinical trials, RIBBON-1 and AVADO data, for first-line HER2-negative metastatic breast cancer in order to convert the accelerated approval in first-line HER2-negative metastatic breast cancer to a full approval.

Genentech is pursuing a broad late-stage clinical development program with Avastin, evaluating its potential use in multiple tumor types with a variety of chemotherapy regimens and in combination with other targeted therapies such as Apomab, dulanermin (rhApo2L/TRAIL), the Hedgehog Pathway Inhibitor, Herceptin, MetMAb, Rituxan, and Tarceva. Avastin is being studied worldwide in more than 450 clinical trials and in more than 30 different tumor types.

Approved Uses

• In February 2004, the FDA approved Avastin for use in combination with intravenous 5-Fluorouracil (5-FU)-based chemotherapy as a treatment for patients with first-line metastatic cancer of the colon or rectum.
• In June 2006, the FDA approved Avastin for use in combination with intravenous 5-FU-based chemotherapy for patients with second-line metastatic cancer of the colon or rectum.
• In October 2006, the FDA approved Avastin in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.

Read more about Avastin's approved use.

Additional Information on Clinical Trials For inquiries about our clinical trials, please submit a request through our information request form or call (888) 662-6728.

National Institutes of Health Website: www.clinicaltrials.gov

April 2009