Roche announced that the European Commission has approved Tarceva (erlotinib) for use in patients with a genetically distinct type of non-small cell lung cancer (NSCLC) in Europe. This approval will enable the use of Tarceva as a first-line monotherapy in people with locally advanced or metastatic NSCLC with EGFR (epidermal growth factor receptor) activating mutations. Tumours with these mutations are responsive to Tarceva1 and treatment with this medicine has been shown to more than triple the number of patients whose tumours shrink (response rate). Tarceva has also shown to nearly double the time patients live without their disease progressing (progression free survival – PFS) compared to chemotherapy.

"The European approval for Tarceva is good news for patients with a genetically distinct form of lung cancer because these patients may derive greater benefit when the medicine is used as an initial treatment," said Hal Barron M.D., chief medical officer and head, global product development. “Advanced lung cancer is often diagnosed with little warning of symptoms and progresses aggressively so it is important to identify which patients may benefit from early treatment with Tarceva."

Lung cancer is the leading cause of cancer death globally; it kills more people than breast, colon, kidney, liver, skin cancer and prostate, cancers combined. In 2008, there were 1.6 million new cases of lung cancer and each year 1.3 million people die as a result of the disease. It is estimated that 10%-30% of patients with NSCLC have tumours with EGFR activating mutations. Roche Molecular Systems is developing the cobas EGFR Mutation Test, a companion diagnostic for Tarceva, to identify patients with EGFR mutations.   The CE Mark for this test is expected for the second half of 2011.

Tarceva is already approved in Europe for use in advanced or metastatic NSCLC irrespective of a patient’s EGFR status both as maintenance therapy in patients with stable disease immediately after initial chemotherapy and in patients whose disease has progressed following at least one course of chemotherapy.

EGFR is a protein that extends across the cell membrane. The epidermal growth factor (EGF) binds to the part of the EGFR protein that sits on the outside of the cell. Binding leads to activation of the EGFR protein which triggers a complex signalling cascade inside the cell that leads to events including accelerated cell growth and division and development of metastases (tumour growth and spread to other parts of the body). Some NSCLC tumours have activating mutations in the EGFR gene, changing the structure of the EGFR proteins such that they have increased activity.

Tarceva is a once-daily, oral, non-chemotherapy treatment for the treatment of advanced or metastatic NSCLC. It has been shown to potently inhibit EGFR, a protein involved in the growth and development of cancers. Tarceva is a trademark of OSI Pharmaceuticals, LLC, a wholly owned subsidiary of Astellas Holding US Inc. a holding company owned by Astellas Pharma Inc.

This European approval is based on data from the EURTAC (European Randomised Trial of Tarceva vs. Chemotherapy) study which was designed and sponsored by the Spanish Lung Cancer Group (SLCG) and conducted together with investigators from France and Italy in cooperation with Roche. This phase III study demonstrated that Tarceva is superior to chemotherapy in EGFR activating mutation positive NSCLC. It showed that in Western patients first-line Tarceva nearly doubled median progression free survival (9.7 vs. 5.2 months; HR=0.37; p<0.0001) and more than tripled the response rate (58% vs. 15%) compared to chemotherapy.2

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.