Genentech Submits application to US FDA for avastin for brain cancer treatment

04 November 2008

Genentech, Inc. today announced that the company submitted a supplemental biologics license application (sBLA) to the US Food and Drug Administration for Avastin (bevacizumab) as a therapy for people with previously treated glioblastoma.

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.

Glioblastoma is the most aggressive type of brain cancer with no cure and few treatment options. Following initial treatment with chemotherapy and radiation, more than 90 percent of people with glioblastoma will see their cancer return and there are few effective treatments when the initial therapy stops working.

The Avastin application is based on a Phase II clinical trial (Brain) in previously treated glioblastoma that evaluated Avastin as a single agent or in combination with irinotecan chemotherapy.

Genentech says when Avastin was evaluated as a single agent, the study showed that at six months 43 per cent of patients lived without their disease advancing, as defined by progression-free survival (PFS). It said in the study, 28 per cent of patients responded to Avastin, meaning tumours decreased in size by at least 50 per cent.

Genentech also said patients receiving Avastin had a median overall survival of 9.3 months, a secondary endpoint in the study. Most adverse events related to Avastin in this trial appeared to be similar to those previously reported in other Avastin studies. The most common severe (Grade 3 or greater) toxicities in the Avastin-only arm were hypertension (8 per cent) and convulsion (6 per cent). There were two deaths associated with adverse events in the Avastin-only arm. These data, along with those from the combined Avastin and irinotecan study arm, were presented earlier this year at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO).