Genentech files biologics application for Avastin with chemotherapy in lung cancer

By Elaine Rigoli

Tampa, Fla., April 11 - Genentech, Inc. has submitted a supplemental Biologics License Application (sBLA) with the Food and Drug Administration for Avastin (bevacizumab) in combination with platinum-based chemotherapy for first-line treatment of advanced, non-squamous, non-small cell lung cancer.

The submission is based on Genentech's analysis of results from a randomized, controlled, multicenter, phase 3 trial (E4599) that enrolled 878 patients with locally advanced, metastatic or recurrent non-small cell lung cancer with histology other than predominant squamous cell, according to a news release.

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 (based on a hazard ratio of 0.80, which is equivalent to a 20% reduction in the risk of death).

In addition, this study showed that median survival of patients treated with Avastin plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone.

The study also showed a 54% improvement in progression-free survival (based on a hazard ratio of 0.65, a 35% reduction in the risk of progression).

The response rate in patients with measurable disease was 29% in the group receiving Avastin plus chemotherapy, compared to 13% in the group receiving chemotherapy alone.

Genentech has requested priority review on the submission, which means that if accepted, the FDA would take action on the application within six months, or by October, the release said.

The company said it also plans to submit an sBLA for Avastin for the treatment of metastatic breast cancer in the second quarter of 2006.

Avastin is currently approved as a first-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy, the release said.

Genentech is a biotechnology company with headquarters in South San Francisco, Calif.

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