- Roche to Approach World-Wide Regulatory Authorities for a New File
Submission
BASEL, Switzerland, Dec. 11 /Xinhua-PRNewswire/ -- Roche announced today
that a large, international Phase III study (NO16967) of 627 previously
treated patients with advanced colorectal cancer met its primary endpoint of
progression-free survival. Study results showed that the chemotherapy
combination XELOX (oral Xeloda plus oxaliplatin) is as effective in delaying
disease progression as the chemotherapy combination FOLFOX-4 (infused 5-
FU/leucovorin plus oxaliplatin).
"This data endorses previous findings that oral Xeloda in combination
with oxaliplatin may provide a new treatment choice for colorectal cancer
patients," said Eduard Holdener, Head of Global Development at Roche." These
data will be used in the submission to worldwide regulatory authorities to
allow patients with colorectal cancer the opportunity to have an effective
and more convenient therapy."
Xeloda is an oral chemotherapy that can be taken at home and as such it
has an important convenience benefit for both patients and doctors compared
to intravenous infusions which require multiple hospital visits. This
targeted cancer medicine is already used in previously untreated colorectal
cancer patients and last year Xeloda received the additional approval for the
treatment of early (adjuvant) colon cancer.
Results from the NO16967 study will be submitted for presentation at
future major medical meetings.
"Our data complement the findings of the NO16966 study, suggesting that
XELOX is a very reasonable treatment option for patients with recurrent
colorectal cancer," said Mace Rothenberg, MD, lead investigator and Professor
of Medicine at Vanderbilt University Medical Center and Ingram Professor of
Cancer Research at Vanderbilt-Ingram Cancer Center. "By demonstrating that
Xeloda in combination with oxaliplatin was as effective as FOLFOX-4, these
two studies provide the strongest evidence yet that Xeloda may be used in
place of IV 5-FU in the treatment of patients with advanced colorectal
cancer."
In 2004, colorectal cancer was one of the leading cancers and accounted
for 13 percent of all cancers.(1) It is estimated that more than 394,000
people die worldwide from colorectal cancer each year.(2)
About the Study
The NO16967 trial is a large, international phase III trial which
randomized 627 patients from 15 countries world-wide who had previously
received 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 (intravenous bolus and
infusional 5-fluorouracil/leucovorin plus oxaliplatin) in delaying disease
progression or death. The secondary outcomes, to be reviewed included overall
survival, overall response rates, and safety profile.
About XELOX
An abbreviation for a type of combination chemotherapy used to treat
colorectal cancer; it contains Xeloda (capecitabine) plus oxaliplatin.
About Xeloda (capecitabine)
Xeloda is licensed in more than 90 countries worldwide including the EU,
USA, Japan, Australia and Canada and has been shown to be an effective, safe,
simple and convenient oral chemotherapy in treating over 1 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 intravenous (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 is
licensed for the first-line treatment of stomach cancer that has spread, in
South Korea.
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. As a supplier of innovative products and services for the early
detection, prevention, diagnosis and treatment of disease, the Group
contributes on a broad range of fronts to improving people’s health and
quality of life. Roche is a world leader in diagnostics, the leading supplier
of medicines for cancer and transplantation and a market leader in virology.
In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion Swiss
francs. Roche employs roughly 70,000 people in 150 countries and has R&D
agreements and strategic alliances with numerous partners, including majority
ownership interests in Genentech and Chugai. Additional information about the
Roche Group is available on the Internet ( http://www.roche.com ).
All trademarks used or mentioned in this release are legally protected.
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
References:
1. Boyle P, Ferlay J. Cancer incidence and mortality in Europe, 2004.
Annals of Oncology 2005; 16:481-488
2. Boyle P, Langman JS. ABC of colorectal cancer. Epidemiology. BMJ 2000;
321:805-808