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Tarceva Approved in Europe for Lung Cancer


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http://www.medadnews.com/News/index.cfm ... eid=273870

BASEL, Switzerland, September 21, 2005-Thousands of lung cancer patients could now live longer and better if they receive a new cancer treatment – Tarceva – which was approved today across the European Union for patients with locally advanced or metastatic non small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.

Tarceva (erlonitib) has been shown not only to improve survival by an impressive 42.5% but also to improve disease symptoms and quality of life for patients suffering from NSCLC, the most common form of lung cancer. Today’s approval is an important step forward in the fight against this deadly disease – a disease which worldwide claims one life every thirty seconds1 and currently has very few treatment options.

“Tarceva takes lung cancer treatment a step forward, providing patients, whose treatment options are limited, with not only an extended life but one of better quality,” said William M. Burns, CEO Division Roche Pharma. “Its approval across the EU is a continuation of our commitment to ongoing research in the oncology field, with the aim of improving the health and quality of life for people with these devastating diseases.”

Taken as an oral, once-daily therapy, Tarceva is the only EGFR-inhibitor to have demonstrated a survival benefit in lung cancer. Currently most lung cancer patients are treated with chemotherapy which can be very debilitating due to its toxic nature. Tarceva works differently to chemotherapy by specifically targeting tumour cells, so avoiding the unpleasant side-effects of chemotherapy.

“Despite being the biggest cancer killer, lung cancer is an often neglected disease,” said Dr Giuseppi Giaccone, VU Medical Center, Amsterdam. “Over 50 percent of lung cancer patients in Europe are not receiving second-line treatment. With the approval of Tarceva, physicians now have a viable alternative to chemotherapy for their patients.”

Approval Based on Compelling Study Results

The EU approval was based on a pivotal Phase III study recently published in the New England Journal of Medicine (NEJM).2 The study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen’s University with the participation of 86 sites from 17 countries around the world. This Phase III study (NCIC-CTG BR.21) involved 731 patients with advanced NSCLC whose cancers had progressed after first- or second-line chemotherapy. The study compared patients receiving Tarceva monotherapy with placebo.

The key study results were:

• Treatment with Tarceva in patients with advanced NSCLC resulted in significantly longer survival compared to placebo, a 42.5% improvement (6.7 months vs. 4.7 months).

• 31% of patients receiving Tarceva were alive at one year compared to 22% in the placebo arm.

• Patients receiving Tarceva had stability or control of their lung cancer-related symptoms such as cough, shortness of breath and pain, for significantly longer.

• Patients also had a superior quality of life and improved physical function compared to those on placebo.

• The benefits of Tarceva were shown in a broad spectrum of patients.

About Tarceva

Tarceva is an investigational small molecule that targets the human epidermal growth factor receptor (HER1) pathway. HER1, also known as EGFR, is a key component of this signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva blocks tumour cell growth by inhibiting the tyrosine kinase activity of the HER1 signalling pathway inside the cell.

Tarceva is currently being evaluated in an extensive clinical development programme by a global alliance among OSI Pharmaceuticals, Genentech, and Roche. Chugai is pursuing its development and regulatory approval for the Japanese market. In the United States, Tarceva is marketed by Genentech.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

All trademarks used or mentioned in this release are protected by law.

Additional information

- Roche in Oncology

- Lung cancer


1. Global Lung Cancer Coalition. Lung cancer facts: Did you know? www.lungcancercoalition.org/cancer_facts.html. Accessed 12th September 2005.

2. F. Shepherd, J. Rodrigues Pereira, T. Ciuleanu. et al. Erlotinib in Previously Treated Non-Small Cell Lung Cancer, A Trial of the National Cancer Institute of Canada Clinical Trials Group. N Engl J Med 2005;353:123-32.

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