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FDA approved Avastin for brain cancer

Roche gets accelerated approval for Avastin for use in patients with aggressive brain cancer

Roche has been granted accelerated approval of Avastin in people with glioblastoma, the most aggressive form of brain cancer, by the US Food and Drug Administration (FDA).

The new indication for the drug was granted under the FDA's accelerated approval programme, which gives provisional approval to medicines for cancer or other life-threatening diseases. The move follows a unanimous vote by the FDA Oncologic Drugs Advisory Committee (ODAC) on March 31 after early data for Avastin showed significant promise to warrant being considered for accelerated approval.

The National Brain Tumour Society in America welcomed the FDA's decision. "A brain cancer diagnosis is devastating because the tumours invade the brain tissue and can cause rapid deterioration," said director of patient services for the Society, Harriet Patterson. "Until now, people with relapsed glioblastoma have had almost no treatment choices and little hope."

Glioblastoma is one the most aggressive forms of cancer with patients surviving just six to 12 months on average following diagnosis. Around 10,000 people each year in the US are diagnosis with the disease. Following initial treatment with chemotherapy and radiation, more than 90 per cent of patients with glioblastoma will see their cancer return and there are few effective treatments when the initial therapy ends.

The effectiveness of Avastin for glioblastoma is based on an improvement in objective response rate from the BRAIN study and an NCI study. No data are currently available from randomised controlled trials demonstrating an improvement in disease-related symptoms or increased survival with Avastin in glioblastoma.

In a note, analysts ZKB said that at a cost of $50,000 per patient per year Avastin sales could yield additional revenue of $500m for Roche. Analysts forecast suggest that Avastin approval for colon cancer could double sales of the drug.

7th May 2009

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