A member of the Roche Group, Genentech, revealed the U.S. Food and Drug Administration (FDA)'s decision to grant Avastin (bevacizumab) with a Priority Review status alongside the acceptance of the company's supplemental Biologics License Application (sBLA).
Priority Review status is given to medications that is believed by the FDA to have what it takes to significantly improve the effectiveness or safety of a treatment, diagnosis or means of prevention for serious conditions compared to standard methods used. The sBLA filed was based on a Phase III GOG-0240 trial, an independent study sponsored by the National Cancer Institute which assessed the use of Avastin with chemotherapy in women diagnosed with cervical cancer.
"This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer. Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients," said Sandra Horning, M.D., Head of Global Product Development and Chief Medical Officer for Genentech.
Avastin is a prescription-only medication that is designed to be a solution for intravenous infusions. As a biologic antibody, avastin was made to bind to a specific protein known as vascular endothelial growth factor (VEGF). VEGF is important to a tumor's lifecycle because it is responsible for developing and maintaining blood vessels for the tumor. Avastin works by disrupting the blood supply of the tumor by preventing VEGF from function as it should. It is believed that a tumor with inadequate blood supply will not grow and spread.
Over 12,000 cases are estimated to be newly diagnosed in the U.S. this year alone while around 4,000 deaths will result from cervical cancer. There's a marked difference in the rates of survival for the early and the advanced stages of cervical cancer, with nine of 10 cases living five years more after the disease is diagnosed in the early stages. Once the cancer has spread, the rate of survival drops to less than six out of 10.
Avastin was first approved for use in the U.S. in 2004 as a treatment for the advanced stages of colorectal cancer, making the medication the first anti-angiogenic made publicly available. It has been proven effective in improving progression-free survival or overall survival across different cancer types and has been also approved for use in more than 60 countries all over the world as treatment for progressive glioblastoma patients after prior therapy. More than 1.4 million patients have used Avastin as treatment so far and over 500 clinical trials are ongoing to study the effects of the medication on more than 50 types of tumors.