Avastin receives positive opinion in Europe for first-line treatment of patients with advanced lung cancer

First medicine shown to extend survival of previously untreated patients beyond one year

Roche announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the first-line use of Avastin in the treatment of the most common form of lung cancer, in combination with platinum based chemotherapy*. The CHMP’s decision is based on data from the pivotal US (E4599) study and another phase III Avastin in Lung (AVAiL) study which together demonstrate that Avastin is effective in combination with a broad chemotherapy range.

Lung cancer is responsible for over 3,000 deaths per day worldwide1 and non-small cell lung cancer (NSCLC) is the most common form of the disease accounting for more than 80 percent of all lung cancers.2 Avastin is the only first-line treatment in over a decade that has been shown to extend the life of patients with advanced lung cancer in a disease for which patients typically have an average life expectancy of only 8 to 10 months.

“This is a significant day for healthcare professionals and patients as it brings access to Avastin, with its proven ability to extend life in an extremely difficult to treat disease, one step closer to reality” said Professor Christian Manegold, Professor of Medicine, Heidelberg University, University Medical Center, Mannheim, Germany and Principal Investigator of the AVAiL study. “I believe that Avastin is such an innovative treatment that it will change not only the current standard of care in NSCLC, but it will also re-write our expectations for patient outcomes.”

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

“The CHMP opinion is encouraging news for European patients fighting a particularly aggressive and debilitating disease" said William M. Burns, CEO Pharmaceuticals Division of Roche. “With our Avastin development program – the biggest trial program in oncology ever – we will continue to develop the best possible treatment approaches to increase survival and improve quality of life of cancer patients.”

In Europe, Avastin was approved in January 2005 and in the US in February 2004 for first-line treatment of patients with metastatic colorectal cancer. It received another approval in the US in June 2006 as a second-line treatment for patients with metastatic colorectal cancer. In October 2006, following priority review, the world’s first angiogenesis inhibitor was approved by the FDA for the treatment of NSCLC). Most recently in April 2007, Avastin was approved in Europe for the first line treatment of women with metastatic breast cancer and in Japan for use in advanced or recurrent colorectal cancer.