EU Grants Broad Approval of Xeloda for Patients With Metastatic Colorectal Cancer
04/02/2008 07:31
PR Newswire
BASEL, Switzerland, February 4 /PRNewswire/ --
- Many More Patients Can Now Benefit From Oral Chemotherapy That
Significantly Reduces Treatment Time
Roche announced today that the European Commission has approved its oral
chemotherapy Xeloda (capecitabine) for the treatment of metastatic colorectal
cancer in combination with any chemotherapy in all lines of treatment with
or without Avastin. This broad approval means that more patients suffering
from colorectal cancer that has spread will now be able to take advantage of
effective and innovative treatments with proven patient benefits.
Approval was based on the pivotal studies demonstrating:
- Xeloda tablets provide patients with a more flexible
treatment option with less hospital treatment time, whilst continuing to
deliver the same survival benefits and safety as the previous standard
chemotherapy intravenous (iv) 5-FU.
- Avastin in combination with chemotherapy allows patients to live
significantly longer without their cancer progressing.
"Colorectal cancer is a devastating disease and treatment options for
patients have been limited," said Professor Jim Cassidy, Cancer Research UK
Professor of Oncology and Chair of Medical Oncology, Beatson Oncology Centre,
at the University of Glasgow, Scotland. "Until now, Xeloda has been available
to only a few colorectal cancer patients. But several studies have now shown
that almost all patients with colorectal cancer that has spread can benefit
from Xeloda at any time and in combination with any chemotherapy treatment.
It is a highly effective oral chemotherapy that reduces hospital treatment
time by 160 hours compared to the old standard chemotherapy, allowing
patients to live as normal a life as possible."
"This approval shows that the EU authorities have endorsed that oral
Xeloda can replace iv 5-FU in all colorectal cancer regimens, making cancer
treatment regimens easier for patients," Professor Cassidy concluded.
It is estimated that more than 400,000 people in Europe will be diagnosed
with metastatic colorectal cancer every year. (1) The previous standard
treatment, iv 5-FU was particularly burdensome on patients. Now oral Xeloda
offers a better alternative that can be used alone or in combination with
oxaliplatin or irinotecan to provide a therapy that is highly effective, safe
and flexible.
Data submitted to the regulatory authorities that contributed to the
broad approval included pivotal studies on XELOX (Xeloda with oxaliplatin)
with or without Avastin and supporting studies on XELIRI (Xeloda in
combination with irinotecan) with or without Avastin. (2,3)
Notes to Editors:
About the Phase III studies that formed the basis of the approval.
NO16966
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 chemotherapy combination XELOX is as effective in terms of
progression-free survival- a measure of the time patients live without their
disease progressing - as FOLFOX;
- The addition of Avastin to chemotherapy (FOLFOX and XELOX)
significantly improved progression-free survival compared to chemotherapy
alone.
NO16967
The NO16967 trial is a large, international phase III trial which
randomized 627 patients from 15 countries world-wide who had previously
received irinotecan-containing combination chemotherapy and whose disease had
returned or continued to progress. The primary objective was to answer
whether the XELOX regimen (Xeloda plus oxaliplatin) is as effective as
FOLFOX-4 (i.v. bolus and infusional 5-FU/leucovorin plus oxaliplatin) in
terms of progression-free survival. The secondary outcomes to be reviewed
included overall survival, overall response rates, and safety profile. The
results showed:
- The chemotherapy combination XELOX is as effective in terms of
progression-free survival as the chemotherapy combination FOLFOX.
About Xeloda
Xeloda is licensed in more than 100 countries worldwide including the EU,
USA, Japan, Australia and Canada and has been shown to be an effective, safe,
and convenient oral chemotherapy in treating over 1.5 million patients to
date.
Roche received marketing authorisation for Xeloda as a first-line
monotherapy (by itself) in the treatment of metastatic colorectal cancer
(colorectal cancer that has spread to other parts of the body) in most
countries (including the EU and USA) in 2001. Xeloda has also been approved
by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration
(FDA) for adjuvant (post-surgery) treatment of colon cancer in March and June
2005, respectively.
Xeloda is licensed in combination with Taxotere (docetaxel) in women with
metastatic breast cancer (breast cancer that has spread to other parts of the
body) and whose disease has progressed following i.v. chemotherapy with
anthracyclines. Xeloda monotherapy is also indicated for treatment of
patients with metastatic breast cancer that is resistant to other
chemotherapy drugs such as paclitaxel and anthracyclines. Xeloda received
approval in South Korea for the first-line treatment of patients with locally
advanced (metastatic) pancreatic cancer, in combination with gemcitabine.
Xeloda is licensed in South Korea for the first-line treatment of stomach
cancer, and has recently received EU approval for the first-line treatment of
advanced stomach cancer in combination with a platinum agent. In Japan it is
licensed in post-surgery colon cancer and advanced breast cancer.
The most commonly reported adverse events with Xeloda include diarrhoea,
abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar
erythrodysesthaesia).
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading
research-focused healthcare groups in the fields of pharmaceuticals and
diagnostics. Additional information is available on the Internet at
http://www.roche.com.
(1) Ferlay J, AutierP et al. Estimates of the cancer incidence and
mortality in Europe in 2006. Annals of Oncology 18: 581-592, 2007.
(2) Koopman M, Antonini N et al. Sequential versus combination
chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced
colorectal cancer (CAIRO): a phase III randomised controlled trial.
Lancet 370: 135-142, 2007
(3) Schmiegel, WH, Reinacher-Schick A et al. Comparable safety and
response rate with bevacizumab in combination with capecitabine/oxaliplatin
(CapOx/Bev) versus capecitabine/irinotecan (CapIri/Bev) in advanced CRC
(mCRC): A randomized phase II study of the AIO GI tumor study group. ASCO
2007 (Astract 4034)
For further information please contact: Julia Pipe, International Communications Manager - Xeloda, F.Hoffmann-La Roche, Mob: +41-79-263-9715, Email: julia.pipe@roche.com; Nerea Hinzpeter, OgilvyHealthPR, Tel: +1-212-625-4178,Email: nerea.hinzpeter@ohpr.com