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29.06.2010 – 11:54

Roche Pharmaceuticals

Tarceva Filed With EU Health Authorities for First-Line Treatment of NSCLC With EGFR Activating Mutations

Basel, Switzerland, June 29, 2010 (ots/PRNewswire)

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) to extend the current label for Tarceva(R) (erlotinib) in non-small cell lung cancer (NSCLC) to include first-line treatment of patients with NSCLC with epidermal growth factor receptor (EGFR) activating mutations.

The filing is based on emerging data from clinical studies and ongoing clinical experience which show that Tarceva provides particular benefit in patients with NSCLC with EGFR activating mutations. Most recently, data presented at the American Society of Clinical Oncology (ASCO) meeting showed that in patients with advanced lung adenocarcinoma (a form of NSCLC) with EGFR activating mutations Tarceva delayed disease progression by a median of 15.7 months. In addition, a promising effect on overall survival (OS) was observed with patients surviving for a median of more than 30 months.[1] By comparison, in patients with a similar diagnosis chemotherapy alone typically delays disease progression by 5-6 months and gives an overall survival of around 12 months. [2]

NSCLC with EGFR activating mutations is considered to be a genetically distinct form of lung cancer which is more common in never smokers, patients with adenocarcinoma, people of Asian origin and females.[3],[4]

In the EU Tarceva is currently indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic NSCLC with stable disease after platinum-based first-line chemotherapy and for the second-line treatment of patients with locally advanced or metastatic NSCLC.

About EGFR in lung cancer

EGFR is a protein which extends across the cell membrane. The epidermal growth factor (EGF) binds to the extracellular part of this protein.[5] Binding leads to activation of an enzyme inside the cell called tyrosine kinase which triggers a complex signalling cascade that leads to events including accelerated cell growth and division, development of metastasis and angiogenesis.[6],[7] Some NSCLC tumours have activating mutations in the EGFR gene, changing the structure of the EGFR proteins that they code for such that they have increased activity.

About Tarceva

Tarceva is a once-daily, oral non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit epidermal growth factor receptor (EGFR), a protein involved in the growth and development of cancers. Tarceva is the first and only EGFR inhibitor to be approved for use in maintenance and second-line treatment settings in patients with advanced or metastatic NSCLC. It is also the only EGFR inhibitor to have shown activity in patients irrespective of EGFR activating mutation status. In both maintenance and second-line settings, Tarceva has a proven and significant survival and symptom benefit without the side effects associated with chemotherapy. In addition, Tarceva in combination with chemotherapy is the first treatment in over a decade to have shown a significant survival benefit in treating patients with pancreatic cancer. Since initial launch Tarceva has been used to treat more than 400,000 patients worldwide and is now approved in more than 100 countries.

About Roche

Information about the Roche Group is available on the Internet at

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[1] Jänne, P.A. et al. J Clin Oncol 28:7s, 2010 (suppl; abstr 7503).

[2] Earle, CC. Chest 2000; 117: 1239-46.

[3] Paz-Ares L, et al; J. Cell. Mol. Med, 2010.

[4] Mitsudomi T, Yatabe Y. Cancer Sci 2007;98:1817-24.

[5] 051308/page3. Accessed 25.03.10

[6] Prenzel N et al. Endocrine-Related Cancer. (2001). 8:11-31.

[7] Britten CD. Mol Cancer Ther; 2004. 3 1335-42.


CONTACT: Federico Maiardi, Roche , Tel: +41-61-688-7946 ,
Mobile:+41-79-264-3978 , email: . Rosemary
Hennings,Galliard , Tel: +44-20-7663-2225, Mobile: +44-7799-411-325,

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