BASEL, Switzerland, Jan. 28 /CNW/ -
- Avastin Receives Broad Label Extension in Europe for the Treatment of
Patients With Metastatic Colorectal Cancer
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 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
- The addition of Avastin to chemotherapy (XELOX or FOLFOX-4)
significantly improved progression-free survival by 20% compared with
- 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.
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
- Roche in Oncology:
- 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.
(1) Ferlay J, Autier P 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.
For further information:
For further information: Roche, Erica Bersin, +41-61-688-2164,
Erica.Bersin@Roche.com; Galliard Healthcare: Dominic Elliston,