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FDA to consider Avastin for brain cancer

Leading biotech company Genentech has submitted an application to the US FDA for Avastin as a treatment for brain cancer

Leading biotech company Genentech has submitted an application to the US Food and Drug Administration (FDA) for Avastin as a treatment for brain cancer.

Genentech has submitted a supplemental Biologics Licence Application (sBLA) to the FDA for Avastin as a therapy for previously treated glioblastoma, the most common and aggressive type of brain tumour.

After initial chemotherapy and radiation treatment, glioblastoma will return in over 90 per cent of cases. There is no cure, and there are few treatment options once the initial therapy ceases to be effective.

The sBLA for Avastin is based on a phase II trial involving 167 patients with relapsed glioblastoma previously treated with chemotherapy and radiotherapy. Subject to acceptance by the FDA, the application is eligible for accelerated approval - a provision for cancer and other life-threatening disease therapies to be approved based on preliminary evidence.

When Avastin was tested as a single agent, at six months 43 per cent of patients lived without their disease advancing. Avastin was also tested in combination with irinotecan chemotherapy. Overall, 28 per cent of patients responded to Avastin, measured by tumours decreasing to at least half their original size.

"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," said Dr Hal Barron, Genentech's senior vice president of development and chief medical officer. "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."

In 2009, the company plans to commence a global phase III study of Avastin with chemotherapy and radiation as a treatment for patients with newly diagnosed glioblastoma.

3rd November 2008

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