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 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, and Apo2L/TRAIL. Avastin is being studied worldwide in more than 300 clinical trials and in more than 20 different tumor types.

We are preparing to submit a supplemental Biologics License Application (sBLA) to the FDA based on the positive interim results of Roche's AVOREN study in first-line metastatic renal cell carcinoma and we are in preliminary discussions with the FDA regarding the submission requirements for a potential sBLA for Avastin in patients with glioblastoma multiforme (a form of brain cancer).

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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