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NICE rejects Roche's Avastin for advanced breast cancer

Decision represents the latest blow to Roche's blockbuster cancer drug

Roche Avastin bevacizumab

Roche has been dealt another blow to its Avastin franchise today after the UK's cost-effectiveness watchdog said it should not be prescribed for first-line treatment of advanced breast cancer.

The National Institute for Health and Clinical Excellence (NICE) said the combination of Avastin (bevacizumab) and another Roche cancer drug called Xeloda (capecitabine) should not be used in metastatic breast cancer patients "for whom other chemotherapy options - including taxanes or anthracyclines - are not considered appropriate".

While Avastin and capecitabine were able to delay the progression of breast cancer, the regimen gave no improvement on overall survival and there was no evidence that it could improve patients' quality of life, according to NICE, which said it was therefore not a cost-effective use of NHS resources. 

The decision is still open to appeal, but is expected to be finalised next month. NICE has previously turned down Avastin for use in combination with a taxane for the first-line treatment of metastatic breast cancer, as well as for first-line treatment of advanced colorectal cancer.

Roche said it was disappointed by the decision because Avastin and capecitabine have proven to be "an important treatment option for women who have a particularly aggressive form of breast cancer which has a poor prognosis".

The drug's role in breast cancer was brought into question last year though, after studies suggested that the risks associated with the drug outweighed its benefits in advanced breast cancer.

In the US, the FDA stripped Avastin of its approval in that indication last November, while in 2010 the EMA restricted its use to only include combination with paclitaxel. Later, the EU agency said treatment alongside Xeloda was also an option. 

Meanwhile, Roche has been extending Avastin's use into other malignancies, particularly ovarian cancer, to help maintain the franchise. The company is also trying to develop a biomarker to help detect patients who stand to benefit most from the drug. Avastin sales came in at 5.3bn Swiss francs ($5.5bn) last year, down 7 per cent.

Women with advanced breast cancer in England who wish to get access to Avastin may be able to do so via the Cancer Drugs Fund, which provides £200m a year for local health authorities to purchase cancer drugs that have not been recommended by NICE.

This option is however not available yet for patients in Wales, Scotland and Northern Ireland. Avastin was the most requested medicine in the Fund between April 2011 and January 2012.

6th July 2012

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