Avastin

Avastin is the first U.S. Food and Drug Administration (FDA) approved therapy designed to inhibit angiogenesis, the process by which new blood vessels develop and carry vital nutrients to a tumor.

Status: The FDA approved Avastin in February 2004. Avastin is approved for use in combination with intravenous 5-Fluorouracil-based chemotherapy as a treatment for patients with first-line — or previously untreated — metastatic cancer of the colon or rectum.

The Avastin FDA approval is based on data from a large, placebo controlled, randomized study demonstrating prolongation in the median survival of patients treated with Avastin plus the IFL(5-FU/Leucovorin/CPT-11) chemotherapy regimen by approximately five months, compared to patients treated with the IFL chemotherapy regimen alone (20.3 months versus 15.6 months). This is one of the largest improvements in survival ever reported in a randomized, Phase III study of patients with metastatic colorectal cancer.