Roche Pharmaceuticals

Innovative Drug Tarceva Now Available in Europe to Tackle Growing Lung Cancer Epidemic

    Basel, Switzerland (ots/PRNewswire) - The news that the innovative new cancer drug Tarceva(R) (erlotinib) is now becoming available across the EU will provide a glimmer of  hope to over 380,000 people in Europe this year who have received the devastating news that they have lung cancer.

    Not only has Tarceva demonstrated a striking survival benefit (42.5 per cent) in advanced non-small cell lung cancer, the most common form of the disease, it has also been shown to significantly improve patients' quality of life by alleviating the severe and debilitating symptoms that characterise advanced disease, such as cough, pain and breathlessness.

    June Sheldon, a 71 year old grandmother, was diagnosed with advanced non-small cell lung cancer April 2002. "I could hardly breathe before and didn't think I would last a year. I'm living proof of the benefit of taking Tarceva, I don't think I would be here otherwise and it made a difference to my life much more quickly than I thought," said June. "Now I go out for lunch two or three times a week and wander around the shops, I really feel I can get on with my life."

    Physicians and patients are crying out for new lung cancer treatments as globally the disease is increasing at such an alarming rate that it is often referred to as an epidemic.(1) The highest rates are seen in parts of  Northern Europe but rates are rapidly increasing in most other parts of the  world. Although incidence rates are unchanged or slightly decreasing in men, both Incidence(2) and mortality rates(3) are dramatically rising in women.

    "There have only been minor improvements in the effectiveness of chemotherapy agents in the last ten years," said Professor Giuseppe Giaccone, VU Medical Center, Amsterdam. "Tarceva is an exciting advance in treatment. It offers a beacon of hope to physicians and patients alike in an area that has long suffered from therapeutic scepticism."

    Many people with advanced non-small cell lung cancer do not receive chemotherapy. This can be for a variety of reasons but is most often because they are too sick to cope with it.

    Chemotherapy can be very debilitating due to its toxic nature. Tarceva, however, delivers effectiveness comparable to chemotherapy but, importantly, without compromising tolerability and overall quality of life.

    "There is still a long way to go in the development of treatments for lung cancer however, Tarceva is an important and exciting step forward," said Dr Jesme Baird, of the patient advocacy organisation the Roy Castle Lung Cancer Foundation in the UK. "It could really improve the lives of people with lung cancer so they can enjoy time with their family and friends and lead as normal a life as possible."

    Beyond its devastating human cost, lung cancer also has a high financial cost on society both in terms of direct costs, such as hospital care, and indirect costs, such as working days lost. The indirect cost of lung cancer is two to three times that of the direct cost and is one of the most important in terms of working years lost.(4) In Germany alone, 59,000 working years and 557,000 total years were lost in 2002 totalling 14.7 billion  Euros(4) not including morbidity costs.

    Tarceva Approval Based on Compelling Study Results

    Tarceva is approved for locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen,

    The EU approval was based on a pivotal Phase III study recently published in the New England Journal of Medicine (NEJM). The study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University, in collaboration with OSI Pharmaceuticals, 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 non-small cell lung cancer (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.

    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, and avoids the typical side-effects of chemotherapy.

    Tarceva is approved in the US and 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 is currently being evaluated in an extensive clinical development programme by a global alliance among OSI Pharmaceuticals, Genentech, and Roche, focussing on earlier stages of NSCLC. Additionally, Tarceva is being studied in combination with Avastin in NSCLC. Trials are also being conducted with Tarceva in other solid tumours, such as ovarian, bronchioloalveolar (BAC), colorectal, pancreatic, head and neck and glioma (brain).

    Roche in Oncology

    The Roche Group, including its members Genentech in the United States and Chugai in Japan, is the world's leading provider of cancer care products, including anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented five products proven to provide survival benefit in different major tumour indications: Avastin, Herceptin, and Xeloda in advanced-stage breast cancer, Herceptin in early-stage HER2-positive breast cancer, MabThera in non-Hodgkin's lymphoma, Avastin and Xeloda in colorectal cancer, Avastin and Tarceva in non-small cell lung cancer and Tarceva in pancreatic cancer.

    In addition to these anti-cancer agents, the Roche oncology portfolio includes a comprehensive collection of medicines that can help improve the quality of life of cancer patients: Bondronat (for prevention of skeletal events in patients with breast cancer and bone metastases, hypercalcaemia of malignancy), Kytril (for chemotherapy and radiotherapy-induced nausea and vomiting), Neupogen (for cancer-related neutropenia), and NeoRecormon (for anaemia in various cancer settings). CERA is the most recent demonstration of Roche's commitment to anaemia management. Other oncology products include Furtulon (for colorectal cancer) and Roferon-A (for hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). The Roche Group's cancer medicines generated sales of more than 7.7 billion Swiss francs in 2004.

    In addition to the medicines, Roche is developing new diagnostic tests that will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, Roche will continue to be the leader in providing cancer-focused treatments and diagnostics.

    The unmatched Roche oncology portfolio as well as an extensive external innovation base through collaborations with companies and academia is what makes it possible for Roche to provide more effective cancer therapies.

    In the United States Herceptin, MabThera (Rituxan), Avastin and Tarceva are marketed either by Genentech alone or together with its partners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines.

    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 legally protected.

    References:

    1. Wilking N and B Jonsson, A Pan European comparison regarding patient access to cancer drug, Karolinska Institute and Stockholm School of Economics, Stockholm, Sweden 2005, A - xv

    2. Wilking N and B Jonsson, A Pan European comparison regarding patient access to cancer drug, Karolinska Institute and Stockholm School of Economics, Stockholm, Sweden 2005, p29

    3. Wilking N and B Jonsson, A Pan European comparison regarding patient access to cancer drug, Karolinska Institute and Stockholm School of Economics, Stockholm, Sweden 2005, p91

    4. Wilking N and B Jonsson, A Pan European comparison regarding patient access to cancer drug, Karolinska Institute and Stockholm School of Economics, Stockholm, Sweden 2005, p15

ots Originaltext: Roche Pharmaceuticals
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