Genentech is looking to get another approval from US regulators for blockbuster Avastin, this time for brain cancer.

The biotechnology firm has submitted a supplemental Biologics License Application to the US Food and Drug Administration for Avastin (bevacizumab) as a therapy for people with previously-treated glioblastoma. The file is based on findings from a Phase II study which showed that 43% of previously-treated patients who were given the drug alone lived six months without their brain cancer advancing.

The data also showed that 28% of patients saw their tumours decrease in size by at least 50% and had a median overall survival of 9.3 months. If accepted by the FDA, Genentech said the new application would be considered for an accelerated approval which involves a six-month review period.

Genentech, citing figures from the National Cancer Institute, noted that 19,000 new cases of glioblastoma, the most common type of brain tumour. are diagnosed in the USA every year. Only 15% of patients usually live six months without their cancer advancing and fewer than 10% respond to treatment.

Genentech's chief medical officer, Hal Barron, said that there has been “no substantial improvement in the treatment of glioblastoma in more than 20 years". He added that “we look forward to working with the FDA to potentially make Avastin the first targeted therapy” for a disease that “desperately needs new treatment options”.

The firm plans to initiate a global Phase III study in patients with newly diagnosed glioblastoma in the first half of 2009. It will evaluate Avastin as a first-line treatment, with standard chemotherapy and radiation.

Another approval would be a major boost for Avastin sales which reached $704 million for the third quarter in the USA, up 18%. It is currently approved as a treatment for patients with colon, lung and breast cancers and is marketed by Genentech’s majority owner Roche elsewhere.