If accepted by the FDA, the application would be considered for an accelerated approval that allows provisional approval of medicines for cancer or other life-threatening diseases based on preliminary evidence suggesting clinical benefit.
The Avastin supplemental biologics license application (sBLA) is based on a Phase II clinical trial in previously treated glioblastoma that evaluated Avastin as a single agent or in combination with irinotecan chemotherapy.
Genentech plans to initiate a global Phase III study in patients with newly diagnosed glioblastoma in the first half of 2009 that will evaluate Avastin with standard of care chemotherapy and radiation.
Hal Barron, chief medical officer of Genentech, said: “There has been no substantial improvement in the treatment of glioblastoma in more than 20 years. This is a devastating disease and people with glioblastoma desperately need new treatment options. We look forward to working with the FDA to potentially make Avastin the first targeted therapy to be approved for the treatment of previously treated glioblastoma.”