Roche Pharmaceuticals

Tarceva Receives Positive Opinion in EU for the Treatment of Patients With Lung Cancer

    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 (immunohistochemistry) testing.

    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.

    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 marketed by Genentech.

    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. 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 law.

    References:

    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.

    4. www.lungcancercoalition.org/cancer_facts.html.

    Additional information

    - Genentech: www.gene.com

    - OSI Pharmaceuticals: www.osip.com

    - Cancer: www.health-kiosk.ch

    - Roche in oncology: www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

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

Contact:
Roche Group Media Office Phone: +41-61-688 8888 / e-mail:
basel.mediaoffice@roche.com, Baschi Durr, Alexander Klauser, Daniel
Piller (Head of Roche Group Media Office), Katja Prowald (Head of
Science Communications), Martina Rupp



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