Roche’s Tarceva gains positive CHMP opinion for first-line use in genetically distinct type of lung





Roche announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion in the EU supporting earlier, frontline use of Tarceva (erlotinib) in people with a genetically distinct type of non-small cell lung cancer (NSCLC). The proposed use of Tarceva is for first-line monotherapy in people diagnosed with advanced EGFR (epidermal growth factor receptor) activating mutation positive NSCLC.

"The CHMP positive opinion for Tarceva is an important step in bringing a personalised medicine option to people with lung cancer. If approved for treatment of lung cancer with EGFR activating mutations, Tarceva will offer patients with this type of advanced lung cancer a significant benefit when used as their first line treatment,” said Hal Barron M.D., Chief Medical Officer and Head, Global Product Development.

The use of Tarceva in people with EGFR activating mutation positive advanced NSCLC is supported by a number of studies including two Phase III trials that span both Western and Asian populations. These studies showed that Tarceva significantly increased the time patients live without their disease progressing compared to chemotherapy.1,2 It is estimated that as many as one in ten (10%) Western people with NSCLC and one in three (30%) Asian people with NSCLC have EGFR activating mutations.3 Use of Tarceva is also supported by a safety profile that is well characterised through use in around 400,000 people with NSCLC, with and without EGFR activating mutations.

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

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.4 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).5,6 Some NSCLC tumours have activating mutations in the EGFR gene, changing the structure of the EGFR proteins 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 EGFR, a protein involved in the growth and development of cancers. Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas Pharma Global Development Inc. group of companies.

The CHMP positive opinion is based on data from the EURTAC study which demonstrated that Tarceva is superior to chemotherapy in EGFR activating mutation positive NSCLC. This phase III study 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.1
About Roche

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 2010, 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: www.roche.com