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

Basel, Switzerland (ots/PRNewswire) - Roche announced today thatits innovative, oral cancer medicine Tarceva (erlotinib) has receiveda positive recommendation from the European Committee for MedicinalProducts for Human Use (CHMP) for the treatment of non-small celllung cancer, the most common form of lung cancer.

"This decision is proof of the impressive survival benefit thatTarceva offers patients with late stage lung cancer," said William M.Burns, CEO Division Roche Pharma. "This brings new hope to lungcancer patients who have currently very limited treatment options."

Tarceva is the first and only EGFR-targeted treatment to haveshown a significant survival benefit in patients with non-small celllung cancer (NSCLC) and offers new hope to the 370, 000 peoplesuffering with lung cancer each year in Europe.(1) EGFR is a keycomponent 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 thetreatment of patients with locally advanced or metastatic non-smallcell lung cancer after failure of at least one prior chemotherapyregimen. When prescribing Tarceva, factors associated with prolongedsurvival should be taken into account. No survival benefit or otherclinically relevant effects of the treatment have been demonstratedin patients with EGFR-negative tumours. The CHMP recommendation isbased on data from a pivotal phase III(2) study which comparedTarceva to placebo for the treatment of patients with advanced NSCLC,following failure of first or second-line chemotherapy. Patientsreceiving Tarceva lived significantly longer than those in theplacebo arm. There was also a significant increase in both the lengthof time before patients' disease symptoms deteriorated and the timewhen patients were stable and there was no progression of theircancer. It was also observed that one out of three patients onTarceva was alive at one year as opposed to only one of five in theplacebo group. There is no specific recommendation for EGFR IHC(immunohistochemistry) testing.

Lung cancer is the most common cancer worldwide(3) with 1.2million new cases annually with someone, somewhere dying of thedisease every 30 seconds.(4) NSCLC accounts for almost 80 percent ofall lung cancer cases and there are few treatment options available.

About Tarceva

Tarceva is an investigational small molecule that targets thehuman epidermal growth factor receptor (HER1) pathway. HER1, alsoknown as EGFR, is a key component of this signalling pathway, whichplays a role in the formation and growth of numerous cancers. Tarcevablocks tumour cell growth by inhibiting the tyrosine kinase activityof the HER1 signalling pathway inside the cell.

Similarly to the significant survival benefit in NSCLC, Tarcevahas also shown survival benefit in a phase III study in locallyadvanced or metastatic pancreatic cancer patients. The study met itsprimary endpoint of improving overall survival.

Tarceva is currently being evaluated in an extensive clinicaldevelopment programme by a global alliance among OSI Pharmaceuticals,Genentech, and Roche. Chugai is pursuing its development andregulatory 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'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As a supplier of innovative productsand services for the early detection, prevention, diagnosis andtreatment of disease, the Group contributes on a broad range offronts to improving people's health and quality of life. Roche is aworld leader in diagnostics, the leading supplier of medicines forcancer and transplantation and a market leader in virology. In 2004sales by the Pharmaceuticals Division totalled 21.7 billion Swissfrancs, while the Diagnostics Division posted sales of 7.8 billionSwiss francs. Roche employs roughly 65,000 people in 150 countriesand has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech andChugai. Additional information about the Roche Group is available onthe Internet (www.roche.com).

All trademarks used or mentioned in this release are protected bylaw.


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 erlotinibin patients with advanced non-small cell lung cancer (NSCLC)following failure of 1st line or 2nd line chemotherapy. A NationalCancer 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 PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

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

Roche Pharmaceuticals

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