Tous Actualités
Suivre
Abonner Roche Pharmaceuticals

Roche Pharmaceuticals

Avastin Receives Positive Opinion in Europe for the Treatment of Patients with Metastatic Colorectal Cancer

Basel, Switzerland (ots/PRNewswire)

Roche announced today that
its innovative cancer drug, Avastin has received a positive
recommendation from the European Committee for Medicinal Products for
Human Use (CHMP).
The CHMP has recommended that Avastin (bevacizumab) in combination
with intravenous 5-fluorouracil/folinic acid or intravenous
5-fluorouracil/folinic acid/irinotecan is indicated for first-line
treatment of patients with metastatic carcinoma of the colon or
rectum.
The CHMP's positive recommendation will now be proposed for final
marketing approval by the European Commission. The recommendation is
based on data from a pivotal Phase III study that showed that
patients treated with Avastin plus chemotherapy* lived on average 30%
longer than patients receiving chemotherapy alone (20.3 months versus
15.6 months).[1] Also, on average the addition of Avastin increased
by 71% the amount of time that patients were without disease
progression, compared to patients receiving chemotherapy alone.
"This is very good news for clinicians and patients alike," said
William M Burns, Head of Roche Pharmaceuticals Division. "The CHMP's
positive recommendation represents an important milestone for
Avastin, as it recognises the value that Avastin can add to another
current chemotherapy treatment regimen, in addition to the regimen
used in the pivotal trial. It also confirms the real benefit that it
can offer to patients with advanced colorectal cancer."
Roche, together with Genentech, presently pursues a comprehensive
clinical programme investigating the use of Avastin in advanced
colorectal cancer with other chemotherapies and also expanding into
the adjuvant setting (post operation). As Avastin's mechanism may be
relevant in a number of malignant tumours, Roche and Genentech are
also investigating the potential clinical benefit of Avastin in other
cancers, including non-small cell lung cancer, pancreatic, breast and
renal cell carcinoma. Around 15,000 patients are expected to be
enrolled into clinical trials over the next years worldwide.
In 2000, colorectal cancer was the third most commonly reported
cancer with 945,000 new cases worldwide.2 It is estimated that over
50% of people diagnosed with colorectal cancer will die of the
disease.
About Avastin
Avastin is the first treatment that inhibits angiogenesis - the
growth of a network of blood vessels that supply nutrients and oxygen
to cancerous tissues. Avastin targets a naturally occurring protein
called VEGF (Vascular Endothelial Growth Factor), a key mediator of
angiogenesis, thus interfering with the blood supply that is
essential for the growth of the tumour and its spread throughout the
body (metastasis). It also promotes the effective delivery of
chemotherapy within the tumour.
Avastin is also being explored with other chemotherapy regimens
including Folfox, Xelox, Xeliri and Folfiri and Xeloda monotherapy.
Avastin was approved in February of this year in the US and has
recently received full approval in Israel.
Roche in Oncology
Within the last five years the Roche Group including its partners
Genentech in the US and Chugai in Japan has become the world's
leading provider of anti-cancer treatments, supportive care products
and diagnostics. Its oncology business includes an unprecedented four
marketed products with survival benefit in different major tumour
indications: Xeloda and Herceptin in advanced stage breast cancer,
MabThera in non-Hodgkin's lymphoma, and Avastin in colorectal
carcinoma. In the United States Herceptin, MabThera and Avastin are
marketed either by Genentech alone or together with Biogen Idec Inc.
(MabThera). Outside of the United States, Roche and its Japanese
partner Chugai are responsible for the marketing of these drugs.
The Roche oncology portfolio also includes NeoRecormon (anaemia in
various cancer settings), Bondronat (prevention of skeletal events in
breast cancer and bone metastases patients, hypercalcaemia of
malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and
vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia,
Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is
the most recent demonstration of the commitment to anaemia
management. The Roche Group's cancer medicines generated sales of
more than 5.6 billion Swiss francs in the first nine months of 2004.
Roche is developing new tests, which will have a significant
impact on disease management for cancer patients in the future. With
a broad portfolio of tumour markers for prostate, colorectal, liver,
ovarian, breast, stomach, pancreas and lung cancer, as well as a
range of molecular oncology tests, we will continue to be the leaders
in providing cancer focused treatments and diagnostics.
Roche Oncology has four research sites (two in the US, Germany and
Japan) and four Headquarter Development sites (two in the US, UK and
Switzerland).
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading innovation-driven healthcare groups. Its core businesses are
pharmaceuticals and diagnostics. As a supplier of products and
services for the 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 number one in the global
diagnostics market, the leading supplier of pharmaceuticals for
cancer and transplantation and a market leader in virology. In 2003
prescription drug sales by the Pharmaceuticals Division totalled 19.8
billion Swiss francs, while the Diagnostics Division posted sales of
7.4 billion Swiss francs. Roche employs roughly 65,000 people in 150
countries and has alliances and R&D agreements with numerous
partners, including majority ownership interests in Genentech and
Chugai.
All trademarks used or mentioned in this release are legally
protected.
    References:
    1. Hurwitz, H, Fehrenbacher, L, Novotny, W, et al. Bevacizumab plus
       Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal
       Cancer. New England Journal of Medicine 2004; 350(23): 2335-2342
    2. J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2000: Cancer
       Incidence, Mortality and Prevalence Worldwide, Version 1.0. IARC
       CancerBase No. 5. Lyon, IARCPress, 2001
    For further information:
    Cancer: www.health-kiosk.com
    * Bolus 5-FU/Leucovorin/irinotecan (also known as the Saltz regimen)

Contact:

Media Relations Contacts Phone: +41-61-688-88-88 / e-mail:
basel.mediaoffice@roche.com, - Baschi Durr, - Alexander Klauser, -
Daniel Piller (Head Roche Group Media Office), - Katja Prowald (Head
Science Communications), - Martina Rupp

Plus de actualités: Roche Pharmaceuticals
Plus de actualités: Roche Pharmaceuticals