Basel, Switzerland (ots/PRNewswire)
- Roche announced today that
its innovative, oral cancer medicine Tarceva (erlotinib) has received
a positive recommendation from the European Committee for Medicinal
Products for Human Use (CHMP) for the treatment of non-small cell
lung cancer, the most common form of lung cancer.
"This decision is proof of the impressive survival benefit that
Tarceva offers patients with late stage lung cancer," said William M.
Burns, CEO Division Roche Pharma. "This brings new hope to lung
cancer patients who have currently very limited treatment options."
Tarceva is the first and only EGFR-targeted treatment to have
shown a significant survival benefit in patients with non-small cell
lung cancer (NSCLC) and offers new hope to the 370, 000 people
suffering with lung cancer each year in Europe.(1) EGFR is a key
component of the human epidermal growth factor receptor pathway,
which plays a role in the formation and growth of numerous cancers.
The CHMP has recommended that Tarceva is indicated for the
treatment of patients with locally advanced or metastatic non-small
cell lung cancer after failure of at least one prior chemotherapy
regimen. When prescribing Tarceva, factors associated with prolonged
survival should be taken into account. No survival benefit or other
clinically relevant effects of the treatment have been demonstrated
in patients with EGFR-negative tumours. The CHMP recommendation is
based on data from a pivotal phase III(2) study which compared
Tarceva to placebo for the treatment of patients with advanced NSCLC,
following failure of first or second-line chemotherapy. Patients
receiving Tarceva lived significantly longer than those in the
placebo arm. There was also a significant increase in both the length
of time before patients' disease symptoms deteriorated and the time
when patients were stable and there was no progression of their
cancer. It was also observed that one out of three patients on
Tarceva was alive at one year as opposed to only one of five in the
placebo group. There is no specific recommendation for EGFR IHC
Lung cancer is the most common cancer worldwide(3) with 1.2
million new cases annually with someone, somewhere dying of the
disease every 30 seconds.(4) NSCLC accounts for almost 80 percent of
all lung cancer cases and there are few treatment options available.
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 marketed by Genentech.
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. Additional information about the Roche Group is available on
the Internet (www.roche.com
All trademarks used or mentioned in this release are protected by
1. 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.
2. Shepherd, F. A randomized placebo-controlled trial of erlotinib
in patients with advanced non-small cell lung cancer (NSCLC)
following failure of 1st line or 2nd line chemotherapy. A National
Cancer Institute of Canada Clinical Trials Group (NCIC), (Abstract
#7022), ASCO 2004.
3. World Health Organisation, World Cancer Report, 2003.
- Genentech: www.gene.com
- OSI Pharmaceuticals: www.osip.com
- Cancer: www.health-kiosk.ch
- Roche in oncology:
ots Originaltext: Roche Pharmaceuticals
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Roche Group Media Office Phone: +41-61-688 8888 / e-mail:
, Baschi Durr, Alexander Klauser, Daniel
Piller (Head of Roche Group Media Office), Katja Prowald (Head of
Science Communications), Martina Rupp