FDAnews
www.fdanews.com/articles/61537-roche-applies-with-emea-for-new-avastin-indication

ROCHE APPLIES WITH EMEA FOR NEW AVASTIN INDICATION

August 8, 2006

Roche has filed an application with the European Medicines Agency (EMEA) for its top-selling drug Avastin for use as a treatment for lung cancer. After colorectal and breast cancer, lung cancer is the third type of disease in which the drug has demonstrated an ability to extend patient's lives, Roche said. The EMEA is expected to decide on the use of Avastin in lung cancer by mid-2007. In the U.S., an FDA decision on the same indication is expected by Oct. 11.

Avastin is already approved in Europe for the treatment of patients with metastatic colorectal cancer in combination with chemotherapy. Roche has also recently submitted applications for Avastin to treat advanced breast cancer in Europe and the U.S.