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Avastin Approved in Europe for First-Line Treatment of Patients With Advanced Kidney Cancer
Date:12/19/2007

, breast, lung, and now kidney cancer:
-- February 2004 (US) and January 2005 (EU) - first-line treatment in

patients with metastatic colorectal cancer (CRC)

-- June 2006 (US) - second-line treatment in patients with metastatic CRC

-- October 2006 (US) - first-line treatment in patients with advanced non

small cell lung cancer (NSCLC)

-- March 2007 (EU) - first-line treatment in patients with metastatic

breast cancer

-- April 2007 (Japan) - treatment in patients with recurrent or advanced

CRC

-- August 2007 (EU) - first-line treatment in patients with advanced NSCLC

-- December 2007 (EU) - first-line treatment in patients with advanced RCC

About the AVOREN Study

The AVOREN study is a randomised, controlled, double-blind, phase III study that included 649 patients with advanced kidney cancer from 101 study sites across 18 countries. Study participants received treatment with either Avastin and IFN alpha-2a or placebo and IFN alpha-2a, the standard of care in patients with advanced kidney cancer.
The results of the AVOREN trial showed that by adding Avastin to IFN:

-- Progression free survival (PFS) was almost doubled from a median of 5.4

to 10.2 months

-- Tumour response was significantly increased from 12.8% with IFN alone

to 31.4% when Avastin was added

-- Dose-reduction of IFN did not appear to affect the efficacy of the

combination with Avastin (based on PFS event free rates over time, as

shown by a sub-group analysis)

The study also showed a trend towards improved overall survival; however, these data are still pending. No new or unexpected adverse events were observed.

An interim analysis of AVOREN was performed in December 2006 and the benefits provided by Avastin were so positive that the Drug Safety Monitoring Board recommended that the trial was unblinded and all patients were offered t
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SOURCE Roche
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