Genentech: Pipeline: Avastin

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. We plan to submit an sBLA for the potential treatment of relapsed glioblastoma multiforme (an aggressive type of brain cancer) by the end of 2008.

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 Tarceva, Herceptin, Rituxan, Apomab, rhApo2L/TRAIL, and the Hedgehog Inhibitor. Avastin is being studied worldwide in more than 450 clinical trials and in more than 30 different tumor types.

Avastin is being developed in collaboration with F. Hoffmann-La Roche.

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.

Avastin

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