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Roche given EU approval for lung cancer treatment

Roche's lung cancer drug Avastin (bevacizumab) has been approved today in Europe for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), in combination with platinum-based chemotherapy.

Roche's lung cancer drug Avastin (bevacizumab) has been approved today in Europe for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC), in combination with platinum-based chemotherapy.

The approval is based on data from the US phase III trial (E4599) and the 'Avastin in Lung' (AVAiL) phase III trial and is for the use of Avastin at a dose of 7.5 or 15 mg/kg, in combination with platinum-based chemotherapy, for the first-line treatment of patients with unresectable advanced, metastatic or recurrent NSCLC other than predominantly squamous cell histology.

Roche says that Avastin is the only first-line therapy to demonstrate improved survival benefits beyond one year in patients with advanced NSCLC.

"Avastin is the first and only anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival for patients with colorectal, lung, breast and kidney cancer," said the company in a statement.

Professor Christian Manegold, professor of medicine at Heidelberg University, University Medical Center Mannheim, Germany and Principal Investigator of the AVAiL trial, said: "Lung cancer is an extremely difficult disease to treat and Avastin has proven that it can prolong the life of patients with NSCLC. A treatment like Avastin that breaks through the one year survival barrier is a big step forward. The European approval for Avastin means we can reassess our expectations for lung cancer patient survival."

Avastin was first approved for use in Europe in January 2005 and in the US in February 2004 for first-line treatment of patients with metastatic colorectal cancer, and was approved by the FDA for the treatment of NSCLC in October 2006, following priority review. Most recently in March 2007, Avastin was approved in Europe for the first-line treatment of women with metastatic breast cancer and in April in Japan for use in advanced or recurrent colorectal cancer.

Avastin is also being used in both the US and the UK to treat wet-age-related macular degeneration (AMD) off-label. 

Avastin posted sales of CHF2.9m in global sales in 2006.

2nd September 2008

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