Avastin Combo Therapy Approved for Second-Line CRC

Genentech has received FDA approval for Avastin in combination with intravenous 5-fluorouracil (5-FU)-based chemotherapy for second-line metastatic colorectal cancer. Avastin is also approved as a first-line treatment of metastatic colorectal cancer (CRC) in combination with intravenous 5-FU-based chemotherapy.

The approval is based on results of a randomized, controlled, multicenter Phase III trial that showed patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 had a 25% reduction in the risk of death, the primary endpoint, which is equivalent to a 33% improvement in overall survival, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 13 months compared to 10.8 months for those receiving FOLFOX4 alone.