Navigation Links
Many More Patients Can Now Benefit from Avastin's Proven Survival Benefits
Date:1/27/2008

Avastin Receives Broad Label Extension in Europe for the Treatment of

Patients with Metastatic Colorectal Cancer

BASEL, Switzerland, Jan. 28 /PRNewswire/ -- Roche announced today that the European Commission (EC) has given its approval for the significantly wider use of its anti-angiogenic agent Avastin(bevacizumab) in patients suffering from metastatic colorectal cancer.

This new broader label will now allow Avastin to be used in combination with any chemotherapy, including Roche's oral chemotherapy Xeloda (capecitabine)*, for 1st and later treatment lines in patients with metastatic colorectal cancer. This news means that virtually all patients with metastatic colorectal cancer now have access to Avastin's proven survival benefits. It is estimated that more than 400,000 people in Europe will be diagnosed with colorectal cancer in 2008.(1)

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

The new Avastin label will allow it to be used in combination with every standard fluoropyrimidine based chemotherapy and also allows for combinations with Xeloda or oxaliplatin. Avastin formerly could only be used in combination with IV 5-FU or IV 5-FU/irinotecan-based chemotherapy regimen (2) where it had demonstrated an impressive survival extension of nearly 5 months. Physicians now have the flexibility to use Avastin with a broad variety of standard chemotherapy of their choice in any line of metastatic colorectal cancer.

"This is a major turning point in the treatment of metastatic colorectal cancer patients," said Professor Alberto Sobrero, Head of Medical Oncology, Hospital San Martino, Genoa, Italy. "This approval means that many more patients can benefit from Avastin's significant survival benefits."

The approval of this broad label is based on the results of two large 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 patients live without their disease advancing.

NO16966 study

NO16966 is a large, international phase III trial which recruited 2,034 patients. It was originally planned to compare XELOX vs FOLFOX as first-line treatment in metastatic colorectal cancer. After release of the pivotal Avastin data in colorectal cancer in 2003, the protocol 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 the XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of Avastin to chemotherapy improved progression-free survival compared to chemotherapy alone. The secondary endpoints included overall survival, overall response rates, time to, and duration of, response and 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 with chemotherapy alone.

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

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

E3200 study

The E3200 study is a randomized, controlled, multi-center phase III trial of 829 patients with advanced or metastatic colorectal cancer who had received previous treatment with irinotecan and 5-FU as initial therapy for metastatic disease or as adjuvant therapy. The study showed that patients who received Avastin plus the 5-FU-based chemotherapy regimen known as FOLFOX4 (oxaliplatin/5-FU/leucovorin) had a 25 percent reduction in the risk of death (based on a hazard ratio of 0.75), the primary endpoint, which is equivalent to a 33 percent improvement in overall survival, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 12.9 months, compared to 10.8 months for those 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 broadcast standard, 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 England Journal of

Medicine 2004; 350(23): 2335-42.


'/>"/>
SOURCE Roche
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Fluctuating eye pressure associated with visual field deterioration in glaucoma patients
2. Comparison of obstetric outcomes between on-call and patients own obstetricians
3. Vision restoration therapy shown to improve brain activity in brain injured patients
4. Diabetes appears to increase risk of death for patients with acute coronary syndromes
5. Ambulatory oxygen rarely a benefit in COPD patients without resting hypoxemia
6. Restricting Blood Flow May Help Heart Bypass Patients
7. Patients with Medicaid and those lacking insurance have higher risk of advanced laryngeal cancer
8. Study provides hope that some transplant patients could live free of antirejection drugs
9. Study provides hope that some transplant patients could live free of anti-rejection drugs
10. Longer ambulance journeys boost death risk for seriously ill patients
11. Expenses Overshadow Optimism for Kidney Failure Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2017)... ... April 28, 2017 , ... Children and adolescents who ... experiences than children in the general population. That’s because foster care is designed ... family challenges. While no fault of their own, youth who have experienced trauma ...
(Date:4/28/2017)... ... 28, 2017 , ... Bill Howe started his sewer and drain company in ... Howe joined the team, the Bill Howe brand was born and they began cultivating ... giving back to the San Diego community in which they worked, lived and were ...
(Date:4/28/2017)... ... April 28, 2017 , ... Woolsy Corporation Limited, a leading ... Nova Skin Sciences division, recently announced the launch of Allumière Antiaging Cream, a ... of an anti-aging concentrate. , Anogeissus Leiocarpa Bark Extract and Vitamin ...
(Date:4/27/2017)... ... April 27, 2017 , ... Today, Jefferson Health in Philadelphia ... announced an agreement to create the Jane and Leonard Korman Respiratory Institute in ... Leonard Korman Family Foundation. The collaboration leverages the strengths of each organization and ...
(Date:4/27/2017)... ... 27, 2017 , ... Last night, Christine Collins of New ... for her extraordinary compassion and lifelong dedication to serve others. Since 1997, Home ... the prestigious award each year – identifying a CAREGiver who has exemplified exceptional ...
Breaking Medicine News(10 mins):
(Date:4/19/2017)... , April 19, 2017  SARES•REGIS Group ... it is developing at Conejo Spectrum Business Park ... to Atara Biotherapeutics, Inc. , a biopharmaceutical ... and life-threatening diseases that have been underserved by ... T-cell therapies for cancer, autoimmune and infectious disease. ...
(Date:4/18/2017)... Cogentix Medical, Inc. (NASDAQ: CGNT), a global medical device ... markets with innovative and proprietary products, will release financial ... after the market close on Tuesday, May 2, 2017. ... call and webcast to discuss its financial results the ... p.m. Eastern Time (3:30 p.m. Central Time). Darin ...
(Date:4/18/2017)... -- Research and Markets has announced the addition of ... offering. ... market to grow at a CAGR of 6.35% during the period ... has been prepared based on an in-depth market analysis with inputs ... growth prospects over the coming years. The report also includes a ...
Breaking Medicine Technology: