GENENTECH'S AVASTIN APPROVED FOR LUNG CANCER

The FDA has approved the use of Genentech's Avastin (bevacizumab) in combination with carboplatin and paclitaxel for the initial systemic treatment of patients with unresectable, locally advanced, recurrent or metastatic, non-squamous, non-small-cell lung cancer. This approval was based on an improvement in survival time when Avastin was added to a standard chemotherapy regimen.

The multicenter clinical trial supporting this approval enrolled 878 patients who had not received prior chemotherapy. The median age of the patients was 63, and 46 percent were women. The trial compared the effectiveness of Avastin plus carboplatin and paclitaxel with chemotherapy by carboplatin and paclitaxel alone. The main outcome measure of the study was duration of survival.

The median overall survival time for patients in the Avastin plus carboplatin and paclitaxel arm was 12.3 months versus 10.3 months for patients receiving only carboplatin and paclitaxel.

Avastin, in combination with intravenous 5-fluorouracil-based chemotherapy, was previously approved for first- or second-line treatment of patients with metastatic cancer of the colon or rectum.