EU Grants Broad Approval of Xeloda for Patients With Metastatic Colorectal Cancer

Basel, Switzerland (ots/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)

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

$story.getcontactHeadline()
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