European CHMP issues positive opinion for Roche's Tarceva as maintenance therapy for NSCLC

- 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(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. 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.

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