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New Cancer Drug Tarceva(R) Demonstrates Significant Improvement in Survival, Symptoms and Quality of Life in Lung Cancer Says Landmark New England Journal of Medicine Study

Basel, Switzerland (ots/PRNewswire)

- Results Provide New Hope in Fight Against One of the Most
Deadly Cancers
Treatment with the innovative cancer drug Tarceva(R) in patients
with advanced non-small cell lung cancer (NSCLC) resulted in
significantly longer survival compared to placebo (42.5% improvement)
according to a landmark study published in the New England Journal of
Medicine (NEJM) today. The study also showed an improvement of
symptoms and quality of life in patients treated with Tarceva.(1)
The results provide new hope in the fight against one of today's
most deadly cancers. NSCLC is the most common form of lung cancer
with around one million new cases worldwide each year.(2,3) Few
treatment options exist and mortality is exceptionally high.
"This study is an important medical advance for patients with
advanced lung cancer and publication in an eminent journal such as
the NEJM is testament to the significance of the data," stated Study
Chair, Frances A. Shepherd, M.D., FRCPC, Scott Taylor Chair in Lung
Cancer Research and Medical Oncologist at the Princess Margaret
Hospital, Professor of Medicine at the University of Toronto.
"Current treatment options are limited and their side-effects can be
debilitating. This landmark study showed that Tarceva not only
prolongs survival but also provides new hope by improving lung cancer
symptoms and patients' quality of life."
Tarceva is an oral, once-daily therapy from a novel class of
anti-cancer drugs known as 'EGFR inhibitors' (epidermal growth factor
receptor inhibitors) and it is the first EGFR inhibitor to have
demonstrated a survival benefit in cancer.
Study Design/Outcome
The global study was conducted by the National Cancer Institute of
Canada Clinical Trials Group based at Queen's University and involved
86 sites from 17 countries around the world. This Phase III study
(NCIC-CTG BR.21) involved 731 patients with advanced NSCLC whose
cancers had progressed after first- or second-line chemotherapy. The
study compared patients receiving Tarceva monotherapy with placebo.
Patients taking Tarceva showed a significant improvement in survival
(6.7 months vs 4.7 months). In addition, 31% of patients receiving
Tarceva were alive at one year compared to 22% in the placebo arm.
Patients receiving Tarceva also had stability or control of their
lung-cancer related symptoms for significantly longer and had a
superior quality of life and improved physical function compared to
those on placebo.(1)
Based on this trial data, Tarceva was approved by the FDA in
November 2004, in Switzerland in March 2005 and in Canada in July
2005, for the treatment of patients with locally advanced or
metastatic NSCLC after failure of at least one prior chemotherapy
regimen. Tarceva has recently received a positive recommendation from
the European Committee for Medicinal Products for Human Use (CHMP)
for the treatment of locally advanced or metastatic NSCLC.
About Tarceva
Tarceva is an investigational small molecule that targets the
human epidermal growth factor receptor (HER1) pathway. HER1, also
known as EGFR, is a key component of this signalling pathway, which
plays a role in the formation and growth of numerous cancers. Tarceva
blocks tumour cell growth by inhibiting the tyrosine kinase activity
of the HER1 signalling pathway inside the cell. Similarly to the
significant survival benefit in NSCLC, Tarceva has also shown
survival benefit in a Phase III study in locally advanced or
metastatic pancreatic cancer patients. The study met its primary
endpoint of improving overall survival. Tarceva is currently being
evaluated in an extensive clinical development programme by a global
alliance among OSI Pharmaceuticals, Genentech and Roche. Chugai is
pursuing its development and regulatory approval for the Japanese
market. In the United States, Tarceva is jointly marketed by
Genentech and OSI Pharmaceuticals.
Roche in Oncology
The Roche Group, including its members Genentech in the United
States and Chugai in Japan, is the world's leading provider of cancer
care products, including anti-cancer treatments, supportive care
products and diagnostics. Its oncology business includes an
unprecedented five products proven to provide survival benefit in
different major tumour indications: Avastin, Herceptin, and Xeloda in
advanced-stage breast cancer, Herceptin in early-stage HER2-positive
breast cancer, MabThera in non-Hodgkin's lymphoma, Avastin and Xeloda
in colorectal cancer, Avastin and Tarceva in non-small cell lung
cancer and Tarceva in pancreatic cancer.
In addition to these anti-cancer agents, the Roche oncology
portfolio includes a comprehensive collection of medicines that can
help improve the quality of life of cancer patients: Bondronat (for
prevention of skeletal events in patients with breast cancer and bone
metastases, hypercalcaemia of malignancy), Kytril (for chemotherapy
and radiotherapy-induced nausea and vomiting), Neupogen (for
cancer-related neutropenia), and NeoRecormon (for anaemia in various
cancer settings). CERA is the most recent demonstration of Roche's
commitment to anaemia management. Other oncology products include
Furtulon (for colorectal cancer) and Roferon-A (for hairy cell and
chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma,
renal cell carcinoma). The Roche Group's cancer medicines generated
sales of more than 7.7 billion Swiss francs in 2004.
In addition to the medicines, Roche is developing new diagnostic
tests that 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, Roche will continue to be the leader in providing
cancer-focused treatments and diagnostics.
The unmatched Roche oncology portfolio as well as an extensive
external innovation base through collaborations with companies and
academia is what makes it possible for Roche to provide more
effective cancer therapies.
In the United States Herceptin, MabThera (Rituxan), Avastin and
Tarceva are marketed either by Genentech alone or together with its
partners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of
the United States, Roche and its Japanese partner Chugai are
responsible for the marketing of these medicines.
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 2004
sales by the Pharmaceuticals Division totalled 21.7 billion Swiss
francs, while the Diagnostics Division posted sales of 7.8 billion
Swiss francs. Roche employs roughly 65,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai.
All trademarks used or mentioned in this release are legally
protected.
References:
1. Shepherd F, Rodrigues Pereira J, Ciuleanu T. et al. Erlotinib
in Previously Treated Non-Small Cell Lung Cancer, A Trial of the
National Cancer Institute of Canada Clinical Trials Group. N Engl J
Med 2005;353:123-32.
2. Ferlay J, Bray F, Pisani P and Parkin DM. GLOBOCAN 2002: Cancer
Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5.
version 2.0, IARCPress, Lyon, 2004.
3. www.lungcancercoalition.org/cancer_facts.html.
Further information:
About Roche: www.roche.com
About Genentech: www.gene.com
About cancer: www.health-kiosk.ch
Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e.pdf
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Contact:

For further information on this release, please contact: Anthea
Morris/Claire Martin, Resolute Communications, Ground Floor, The Blue
Building, London, SE1 3LA, +44(0)20-7357-8187

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