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Avastin wins EU approval for advanced renal cancer

The CHMP issues a positive recommendation for Roche's cancer drug Avastin for use in first-line therapy of advanced renal cell carcinoma

The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for Swiss-based Roche's cancer drug Avastin (bevacizumab) for use in first-line therapy of advanced renal cell carcinoma (RCC).

The CHMP's decision is based on data from the pivotal phase III AVOREN trial, which showed that RCC patients taking Avastin added to interferon, lived twice as long without their disease progressing, compared with interferon alone.

Professor Bernard Escudier, who is Head of Immunotherapy and Innovative Therapy Unit at the Institut Gustave-Roussy in Paris and leader of the AVOREN study, said: "The AVOREN study has shown us that Avastin is an effective and safe treatment for patients with kidney cancer. This announcement is very significant because this drug offers new therapeutic options in advanced kidney cancer, where chemotherapy and radiotherapy are not as effective as in other cancers."

In October 2007, Roche's US partner Genentech said it would ban purchases of Avastin by US independent compounding pharmacies, which currently divide vials of the medicine as a replacement for Lucentis (ranibizumab) in wet-AMD, which is the leading cause of blindness in the elderly.

Genentech posted a letter on its company website, saying it would postpone the ban until the beginning of 2008. The original ban was to start at the beginning of November 2007.

Genentech reported Q3 FY07 sales of USD 597m for Avastin. The drug posted a 37 per cent increase, compared with the same quarter of FY06 and exceeded analysts' sales expectations.

30th September 2008

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