SOUTH SAN FRANCISCO, Calif. — March 9th, 2009 — Genentech, Inc. announced today that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will discuss the company's supplemental Biologics License Application (sBLA) for Avastin® (bevacizumab) for people with previously treated glioblastoma during an advisory committee meeting on March 31, 2009.
The company submitted the application for Avastin under the FDA's accelerated approval program that allows provisional approval of medicines for cancer or other life-threatening diseases based on preliminary evidence likely to predict clinical benefit. The FDA is expected to make a decision on the application by May 5, 2009.
Glioblastoma is the most aggressive form of brain cancer, affecting approximately 10,000 people per year in the United States, according to the National Cancer Institute. Following initial treatment, nearly all people with glioblastoma will experience a return of this rapidly progressing cancer.
The application is based on positive, independently reviewed data from the non-comparative Phase II BRAIN study (AVF 3708g), the largest Avastin clinical trial to date in previously treated glioblastoma (167 patients). The data were presented at the 44th Annual Meeting of the American Society of Clinical Oncology in June 2008.
A global Phase III study will be initiated later this year to evaluate the safety and efficacy of Avastin in combination with radiotherapy and temozolomide for patients with newly diagnosed glioblastoma.
Avastin is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis. Glioblastomas express high levels of VEGF and develop an extensive network of tumor blood vessels. VEGF is a potent activator of angiogenesis throughout the lifecycle of a tumor and is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).
Avastin is indicated for the first- and second-line treatment of metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy and for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel.
Patients treated with targeted therapies, including Avastin, may experience side effects. In clinical trials, some patients treated with Avastin experienced serious side effects, including:
Gastrointestinal (GI) perforation:
Treatment with Avastin can result in the development of a potentially serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, these events occurred throughout the course of treatment, and in some cases resulted in fatality. Avastin therapy should be permanently stopped in people with GI perforation.
Wound healing problems:
Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Avastin therapy should be permanently stopped in patients with wound healing problems that require medical treatment. The appropriate waiting time between stopping treatment with Avastin and having surgery has not been determined.
Some people receiving Avastin with chemotherapy for lung cancer experienced hemoptysis (coughing up blood). In some cases, this event resulted in fatality. People with recent hemoptysis should not receive Avastin.
In clinical trials, additional serious side effects seen across different cancer types include a higher risk of stroke or heart problems (blood clots and congestive heart failure) in some cases resulting in fatality, compared with people taking chemotherapy alone. Some people experienced a condition that causes reduced white blood cell counts that may increase the chance of infection (neutropenia). Some people experienced the formation of an abnormal passage from parts of the body to another part (non-GI fistula formation). Severe high blood pressure, kidney problems, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome) were also experienced by some people take Avastin with chemotherapy. Patients receiving Avastin should have their blood pressure monitored every 2 to 3 weeks.
Avastin may cause problems getting pregnant. People who are pregnant or thinking of becoming pregnant, should talk with their doctor about the potential risks of loss of pregnancy or the potential risk of Avastin to the fetus. Nursing mothers should not breast-feed while receiving Avastin, or for a short period of time after treatment is finished.
For full Prescribing Information and Boxed WARNINGS on Avastin, visit http://www.avastin.com.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.