BN003644 11 de dezembro de 2006 14:28 HORALOCAL
Roche to Approach World-Wide Regulatory Authorities for a New File
Submission
BASEL, Switzerland, Dec. 11 /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
SOURCE Roche
12/11/2006
CONTACT: Baschi Durr, Alexander Klauser, Daniel Piller, Head Roche
Group Media Office, Katja Prowald, Head Science Communications, or
Martina Rupp, +41-61-688-8888, basel.mediaoffice@roche.com, all of
Roche
Web site: http://www.health-kiosk.ch/start_krebs
http://www.roche.com
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
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