Avastin

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FDA asked to approve AVASTIN for lung cancer

Source: (cancerfacts.com)

Wednesday, April 12, 2006

SAN FRANCISCO – April 12, 2006 – Genentech, Inc. announced that it has applied for FDA approval of its anti-angiogenesis cancer drug, Avastin® (bevacizumab), for first-line treatment of advanced, non-small cell lung cancer in combination with platinum-based chemotherapy.

The drug bevacizumab (bev-ah-SI-zoo-mab) has already been approved for treatment in conjunction with chemotherapy of advanced metastatic colorectal cancer. Avastin is an engineered antibody designed to specifically target the Vascular Endothelial Growth Factor (VEGF) protein, which plays a key role in blood vessel growth. By blocking the VEGF protein, Avastin interferes with the tumor's ability to grow the blood vessels needed to sustain growth and provide access to the blood stream to spread or metastasize to other parts of the body.

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

The application is based on results from a large multicenter clinical trail trial (E4599) involving 878 patients comparing a current standard regimen for non-small cell lung cancer and the same regimen plus Avastin.

The results showed that patients receiving Avastin plus paclitaxel and carboplatin chemotherapies had a 25 percent improvement in overall survival compared to patients who received chemotherapy alone. In addition, this study showed that patients treated with Avastin plus chemotherapy survived a median 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone. Median survival is the midpoint of the survival range, meaning 50 percent of the patients in the study survived longer than that and 50 percent survived less than that.

"This is the first time that (median) patient survival was extended beyond one year in a clinical study of advanced non-small cell lung cancer," said Dr. Alan Sandler, director of Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville. "(This is) a disease that typically has a one-year survival rate of 30 to 35 percent. If approved for this indication, Avastin may have the potential to be part of an entirely new approach to treating patients with this type of lung cancer."

The study also showed a 54 percent improvement in length of time patients survived with no further tumor growth before the cancer again began to advance. The number of patients who responded to the regimen was also significantly higher with 29 percent in the group receiving Avastin and chemotherapy responding compared to 13 percent of the group receiving 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. "We are committed to working with the FDA throughout the review process of this application."

The most common side effects experienced by patients in E4599 trial was a loss of infection-fighting white blood cells (neutropenia), which occurred in 27 percent of patients treated with Avastin plus chemotherapy and 17 percent of patients who received chemotherapy alone. Three cases of fatal infection with serious or severe (grade 3/4) neutropenia occurred in the Avastin plus chemotherapy group, compared to none in the chemotherapy alone group. High blood pressure occurred in 8 percent in the Avastin plus chemotherapy group and less than one percent in the chemotherapy-alone group. Other side effects included blood clots forming in the blood vessels, which occurred in more patients in the Avastin group than the chemotherapy alone group.