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
http://www.roche.com.

For further information please contact:

References

---------------------------------

[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] http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_
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.

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

Contact:
CONTACT: Federico Maiardi, Roche , Tel: +41-61-688-7946 ,
Mobile:+41-79-264-3978 , email: federico.maiardi@roche.com . Rosemary
Hennings,Galliard , Tel: +44-20-7663-2225, Mobile: +44-7799-411-325,
email:rhennings@galliardhealth.com