Genentech has requested priority review on the submission, which means that if accepted, the FDA should take action on the application within six months or in October 2006.
The company also plans to submit a similar application for Avastin for the treatment of metastatic breast cancer in the second quarter 2006.
Avastin is currently approved as a first-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy.
The sBLA submission is based on Genentech’s analysis of results from a multicenter phase III trial that enrolled 878 patients with locally advanced, metastatic or recurrent non-small cell lung cancer with histology other than predominant squamous cell.
The results showed that patients receiving Avastin plus paclitaxel and carboplatin chemotherapies had a 25% improvement in overall survival, the trial’s primary endpoint, compared to patients who received chemotherapy alone.
“These data are an important advance in lung cancer research and we look forward to the potential of bringing new hope to the patients who are diagnosed with this specific type of lung cancer,” said Dr Hal Barron, Genentech’s senior vice president of development and chief medical officer.