2008-01-28

Many More Patients Can Now Benefit From Avastin's Proven Survival Benefits


Basel, Switzerland (ots/PRNewswire) -

- Avastin Receives Broad Label Extension in Europe for theTreatment of Patients With Metastatic Colorectal Cancer

Roche announced today that the European Commission (EC) has givenits approval for the significantly wider use of its anti-angiogenicagent Avastin (bevacizumab) in patients suffering from metastaticcolorectal cancer.

This new broader label will now allow Avastin to be used incombination with any chemotherapy, including Roche's oralchemotherapy Xeloda (capecitabine)*, for 1st and later treatmentlines in patients with metastatic colorectal cancer. This news meansthat virtually all patients with metastatic colorectal cancer nowhave access to Avastin's proven survival benefits. It is estimatedthat more than 400,000 people in Europe will be diagnosed withcolorectal cancer in 2008.(1)

The Avastin approval follows the European Committee for MedicinalProducts for Human Use (CHMP) positive recommendations for theextended use of both Avastin and Xeloda in December 2007. *The finalEC decision on Xeloda for its extended use is expected imminently.

The new Avastin label will allow it to be used in combination withevery standard fluoropyrimidine based chemotherapy and also allowsfor combinations with Xeloda or oxaliplatin. Avastin formerly couldonly be used in combination with IV 5-FU or IV 5-FU/irinotecan-basedchemotherapy regimen (2) where it had demonstrated an impressivesurvival extension of nearly 5 months. Physicians now have theflexibility to use Avastin with a broad variety of standardchemotherapy of their choice in any line of metastatic colorectalcancer.

"This is a major turning point in the treatment of metastaticcolorectal cancer patients," said Professor Alberto Sobrero, Head ofMedical Oncology, Hospital San Martino, Genoa, Italy. "This approvalmeans that many more patients can benefit from Avastin's significantsurvival benefits."

The approval of this broad label is based on the results of twolarge international phase III pivotal studies (NO16966 and E3200).

About the Phase III studies that formed the basis of the approval

Note: Progression-free survival is a measure of the time patientslive without their disease advancing.

NO16966 study

NO16966 is a large, international phase III trial which recruited2,034 patients. It was originally planned to compare XELOX vs FOLFOXas first-line treatment in metastatic colorectal cancer. Afterrelease of the pivotal Avastin data in colorectal cancer in 2003, theprotocol was amended to investigate using a 2 by 2 factorial design:FOLFOX/XELOX + placebo vs FOLFOX/XELOX + Avastin.

The primary objective was to answer two questions: 1) whether theXELOX regimen is non-inferior to FOLFOX; 2) whether the addition ofAvastin to chemotherapy improved progression-free survival comparedto chemotherapy alone. The secondary endpoints included overallsurvival, overall response rates, time to, and duration of, responseand safety profile. Results of the study showed:

- The addition of Avastin to chemotherapy (XELOX or FOLFOX-4)significantly improved progression-free survival by 20% compared withchemotherapy alone.

- In patients that received treatment until disease progression,the benefit was even greater, and adding Avastin to chemotherapyimproved progression-free survival by 58%.

- The chemotherapy combination XELOX is as effective in terms ofprogression-free survival as FOLFOX.

E3200 study

The E3200 study is a randomized, controlled, multi-center phaseIII trial of 829 patients with advanced or metastatic colorectalcancer who had received previous treatment with irinotecan and 5-FUas initial therapy for metastatic disease or as adjuvant therapy. Thestudy showed that patients who received Avastin plus the 5-FU-basedchemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin)had a 25 percent reduction in the risk of death (based on a hazardratio of 0.75), the primary endpoint, which is equivalent to a 33percent improvement in overall survival, compared to patients whoreceived FOLFOX4 alone. Median survival for patients receivingAvastin plus FOLFOX4 was 12.9 months, compared to 10.8 months forthose receiving FOLFOX4 alone.

Additional information

- Roche in Oncology:http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk, Cancer:http://www.health-kiosk.ch/start_krebs

- Avastin: http://www.avastin-info.com

To access video clips about Avastin and Xeloda, in broadcaststandard, free of charge, please go to: http://www.thenewsmarket.com.

References

(1) Ferlay J, AutierP et al. Annals of Oncology 18: 581-592, 2007.

(2) Hurwitz H, Fehrenbacher L, Novotny W et al. New EnglandJournal of Medicine 2004; 350(23): 2335-42.

ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

$story.getcontactHeadline()For more information please contact: Roche, Erica Bersin, +41-61-688-2164, Erica.Bersin@Roche.com. Galliard Healthcare: DominicElliston, +44-207-663-2266, Delliston@galliardhealth.com

Roche Pharmaceuticals

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