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

Avastin offers patients the chance to live twice as long without their

disease advancing

BASEL, Switzerland, Dec. 19 /PRNewswire/ -- Avastin (bevacizumab), Roche's innovative anti-cancer drug, was approved today in Europe for the first-line treatment of patients with advanced renal cell cancer (RCC) in combination with interferon (IFN), the current standard of care*. Kidney cancer, known as renal cell carcinoma (RCC) is a disease that kills over 100,000 people per year world-wide(1).

There are few early symptoms in kidney cancer which means that unfortunately the majority of patients are diagnosed with advanced disease, where current treatment options are limited. Kidney cancer is highly resistant to chemotherapy and radiotherapy, which are often key weapons against other cancer types(2).

The approval was based on data from the pivotal phase III AVOREN trial, which showed that patients with advanced RCC who received Avastin in combination with IFN lived nearly twice as long without their disease progressing ("progression free survival"), as those who received IFN alone.

"The results of the AVOREN study confirmed that Avastin is a safe, effective and well tolerated treatment option for patients with advanced renal cell cancer," said Professor Bernard Escudier, Head of the Immunotherapy and Innovative Therapy Unit, Institut Gustave-Roussy, Paris, France and Principal Investigator of the pivotal AVOREN study. "Avastin effectively doubles the time in which patients live without their disease getting worse, so this approval has the potential to change the treatment landscape for this disease, where treatment options are still limited."

Avastin Approval Status

Kidney cancer is the fourth cancer type in which Avastin has demonstrated positive survival benefits for patients. Data from the comprehensive Avastin cancer clinical development programme have resulted in approvals in advanced colorectal, 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 treatment with Avastin. The study demonstrated for the first time that Avastin benefits patients in combination with an immunotherapeutic, the class of drugs to which IFN belongs.

*The approval is for the use of Avastin in patients with advanced and/or metastatic RCC in combination with IFN.

References

1. Parkin DM, Bray F, Ferlay J and Pisani P. 2002. CA Cancer J Clin, 2005; 55: 74-108.

2. De Mulder, PHM. Ann Oncol, 2007; 18 (Supplement 9): ix98-ix102.


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SOURCE Roche
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