Genentech wins FDA approval for new indication of Avastin

Genentech, a biotechnology company, has reported that FDA has granted accelerated approval of Avastin for people with glioblastoma with progressive disease following prior therapy.

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.

The accelerated approval is based on independently reviewed data from an open-label, multicenter, non-comparative Phase II study that included 167 patients with glioblastoma that had progressed following initial treatment with temozolomide and radiation.

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 company said.

Hal Barron, chief medical officer of Genentech, said: This 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. A global Phase III trial in patients with newly diagnosed glioblastoma will soon begin enrollment to further evaluate Avastin in this setting.