Roche applies for drug license extensions

04/17/07 - newratings.com

LONDON, April 17 (newratings.com) – Pharmaceuticals giant Roche Holdings AG (RHO) Tuesday announced that it had filed applications with the US Food and Drug Administration (FDA) for license extensions for the Avastin and Xeloda drugs.

Avastin is an anti-angiogenic agent, while Xeloda is used in oral chemotherapy. The application is for allowing the use of Xeloda (capecitabine) and Xelox (oxaliplatin), with or without Avastin (bevacizumab), for the treatment of metastatic colorectal cancer. The application is based on the results from two international Phase III studies that showed that the combination is as effective as the currently used treatment, FOLFOX-4.