Genentech, Inc. announced that the U.S. Food and Drug Administration (FDA) granted accelerated approval of Avastin (bevacizumab) for people with glioblastoma with progressive disease following prior therapy.
The effectiveness of Avastin in this aggressive form of brain cancer is based on an improvement in objective response rate.
Currently, no data are available from randomized controlled trials demonstrating an improvement in disease-related symptoms or increased survival with Avastin in glioblastoma.
The new indication for Avastin was granted under the FDA’s accelerated approval program that allows provisional approval of medicines for cancer or other life-threatening diseases.
“People with this type of brain cancer have had no new treatments in more than a decade,” said Timothy Cloughesy, M.D., director, Neuro-Oncology Program of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles. “After so many years with little progress in this field, Avastin was associated with a durable tumor response and doctors now have a new medicine to offer patients.”
“Today’s approval would not have been possible without the dedication of physicians, patient advocates, the FDA and most importantly the people who participated in the clinical trials and their families who had the courage to support them,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “A global Phase III trial in patients with newly diagnosed glioblastoma will soon begin enrollment to further evaluate Avastin in this setting.”
Glioblastoma affects approximately 10,000 people per year in the United States and glioblastoma tumors nearly always return following initial treatment.
Source: Genentech, USA