Basel, Switzerland, March 19, 2010 (ots/PRNewswire) - Roche (SIX: RO,
ROG; OTCQX: RHHBY) today announced that the European Committee for
Medicinal Products for Human Use (CHMP) has issued a positive opinion
for use of Tarceva(R) (erlotinib) as a maintenance therapy for people
with advanced non-small cell lung cancer (NSCLC) and stable disease
(cancer remains largely unchanged) after initial chemotherapy. The
CHMP positive opinion clears the way for European Union approval and
means that this group of patients may soon be able to benefit from
earlier treatment with Tarceva.

"Advanced lung cancer is an aggressive disease and when the
cancer grows or spreads the health of many patients deteriorates
rapidly. By giving Tarceva earlier after chemotherapy, instead of
waiting for the disease to progress, we can help more patients live
longer without their disease getting worse", said Professor Federico
Cappuzzo, M.D., Head of Oncology Unit, Livorno Hospital, Italy and
principal investigator of the SATURN trial.

The CHMP positive opinion is based on data from the pivotal phase
III SATURN trial[1]. SATURN showed that Tarceva given as maintenance
therapy early after first-line chemotherapy helped delay disease
progression (PFS) and extended overall survival (OS) compared to
placebo in a broad range of advanced NSCLC patients. Patients with
stable disease (SD) had a more pronounced OS benefit when Tarceva
maintenance therapy was given. This new approach to treatment would
therefore offer these patients, whose cancer can often progress
rapidly, a new and effective oral option to continue treating their
disease.

Tarceva is already approved in the EU for the second-line
treatment of patients with advanced NSCLC [2].

Lung cancer is the most common cancer worldwide with 1.5 million
new cases annually[3] and NSCLC accounts for almost 85% of all lung
cancers[4]. NSCLC progresses rapidly; less than 5% of advanced NSCLC
patients survive for five years[4]. Extending the time patients with
NSCLC live and managing side effects of treatment are key treatment
goals.

About SATURN
- A global multicentre, double-blind, randomised, prospective phase III
study to evaluate the efficacy of Tarceva compared to placebo in patients
with advanced, recurrent or metastatic NSCLC whose disease had not
progressed following first line platinum-based chemotherapy. The study
involved more than 880 patients from approximately 160 centres; 438
received Tarceva and 451 placebo. It showed a statistically significant
improvement in both PFS and OS for Tarceva recipients compared to
placebo[1].
- The statistically significant improvement in both PFS and OS
demonstrated in the group of patients with SD was greater than that shown
in the overall population. Data for patients with SD will be presented at
a forthcoming scientific meeting.
- There were no new or unexpected safety signals in the SATURN study and
adverse events were consistent with those previously reported for Tarceva
in NSCLC.

About Tarceva

Tarceva is different from conventional chemotherapies and has
been shown to potently inhibit EGFR. It is the first and only EGFR
oral targeted agent in second-line with a proven and significant
survival and symptom benefit in a broad range of patients with
advanced lung cancer without the side effects associated with
chemotherapy. Tarceva has been approved in the EU since September
2005 and in the US since November 2004 for the treatment of patients
with locally advanced or metastatic NSCLC with or without EGFR
activating mutations after failure of at least one prior chemotherapy
regimen.

Furthermore, 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. It is approved
in the US in combination with gemcitabine for the first line
treatment of patients with locally advanced, unresectable or
metastatic pancreatic cancer and in the EU for treatment of
metastatic pancreatic cancer.

About Roche

Information about the Roche Group is available on the Internet at
http://www.roche.com .

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

References

[1] Cappuzzo, F et al. Abstract 22LBA. Eur J Canc Supplements,
Vol 7, Issue 3, 2009.

[2] Shepherd FA et al. N Engl J Med 2005; 353:123-132.

[3] Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA:
American Cancer Society, 2007.

[4] Allen J et al. J Natl Compr Canc Netw 2008; 6(3): 285-93.

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

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