Basel, 22 March 2010

Approval would allow patients to benefit from earlier use of well-tolerated oral treatment

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® (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 cancers4.  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.

  • 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.

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.

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80'000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information:

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


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.