| FDA Advisory Committee Unanimously Recommends Accelerated Approval of Avastin for Previously Treated Brain Cancer (Glioblastoma) |
Silver Spring, Md. -- March 31, 2009 -- Genentech, Inc. announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously that the response seen with Avastin® (bevacizumab) in people with previously treated glioblastoma is of sufficient magnitude to be reasonably likely to predict clinical benefit. The FDA is expected to make a decision whether to grant accelerated approval of Avastin for use in this most aggressive form of brain cancer by May 5, 2009. "We look forward to working with the FDA to potentially provide people with this devastating disease the first new treatment in more than a decade," said David Schenkein, M.D., senior vice president, Clinical Hematology and Oncology, Genentech. "A global Phase III trial evaluating Avastin in people with newly diagnosed glioblastoma will be initiated later this year." About Glioblastoma Avastin Application for Accelerated Approval
No new safety signals were observed in the trial and the safety profile was consistent with Avastin experience in other tumor types. The most common severe (Grade 3 or greater) adverse events in patients treated with Avastin alone were high blood pressure (8 percent) and seizures (6 percent). There were two deaths associated with adverse events in the group of patients treated with Avastin alone. AVF3708g was an open-label, multicenter study that evaluated Avastin alone or in combination with irinotecan in previously treated glioblastoma. All patients had previously progressed on prior temozolomide and radiation. The two primary endpoints of the study were objective response rate and six-month progression-free survival (PFS). Response rate was defined as a decrease in tumor size by at least 50 percent on two consecutive independent assessments at least four weeks apart. Six-month PFS was defined as the number of patients who lived six months without their disease getting worse. Secondary endpoints included overall survival and safety. About Avastin Avastin is approved 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. Avastin Safety Gastrointestinal (GI) perforation: Wound healing problems: Severe bleeding: In clinical trials, additional serious side effects seen across different cancer types included 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 taking Avastin with chemotherapy. Patients receiving Avastin should have their blood pressure monitored every two to three 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. About Genentech |