Roche Holding AG

New Hope in Fight Against Advanced Lung Cancer

    Basel, Switzerland (ots/PRNewswire) -

    - Roche files marketing application for Tarceva with European health authorities

    Roche today submitted a Marketing Authorisation Application to the European health authorities for its new cancer drug Tarceva (erlotinib) for the treatment of advanced non-small cell lung cancer (NSCLC). NSCLC is the most common form of lung cancer, which in itself is the most frequent cancer world wide. The application is based on data from a pivotal clinical trial involving more than 700 patients with advanced NSCLC who had failed first or second-line chemotherapy. Patients with advanced NSCLC treated with Tarceva achieved a significant improvement (42%) in survival compared to those on placebo, along with improved symptom benefit(1).

    "The benefits of Tarceva in this patient group are very compelling. Tarceva represents the first significant advance in survival, among targeted therapies, for lung cancer patients who have failed available chemotherapy. In the study, one out of three patients on Tarceva were alive at one year as opposed to only one of five in the placebo group. We will work closely with regulatory authorities to bring Tarceva to patients as quickly as possible" said William M Burns, Head of Roche Pharmaceuticals Division.

    Lung cancer is the most common cancer worldwide, accounting for 1.2 million new cases annually(2) with someone, somewhere dying of lung cancer every 30 seconds (3). NSCLC accounts for almost 80 percent of all types of lung cancer and has few treatment options.

    Tarceva is the first and only EGFR-targeted anticancer treatment to have shown a significant survival prolongation in lung cancer. An application for approval of Tarceva in advanced NSCLC was also filed with the US FDA this month.

    Study Details

    The EU filing is based on results of the pivotal Phase III randomised trial (BR21) involving 731 patients, which compared the use of Tarceva versus placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. Patients receiving Tarceva lived significantly longer than those in the placebo arm (6.7 months vs 4.7 months), an improvement of 42%.1 The study also met all of its secondary endpoints including improving time to symptomatic deterioration, progression-free survival and response rate. In addition, there was a 45% improvement in survival at one year and further analysis showed treatment benefit over 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. Results of a Phase III trial of Tarceva in pancreatic cancer are expected during the second half of 2004 and Tarceva is currently being evaluated in an extensive clinical development program by a global alliance among OSI Pharmaceuticals, Genentech, and Roche. Chugai is pursuing its development and regulatory approval for the Japanese market.

    Roche in Oncology

    Within the last five years the Roche Group including its partners Genentech in the US and Chugai in Japan has become the world's leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit in different major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin's lymphoma, and Avastin in colorectal carcinoma. In the United States Herceptin, MabThera and Avastin are marketed either by Genentech alone or together with Biogen Idec Inc. Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these drugs.

    The Roche oncology portfolio also includes NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcaemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of the commitment to anaemia management. The Roche Group's cancer medicines generated sales of more than 3.3 billion Swiss francs in the first half of 2004.

    Roche is developing new tests, which 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, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

    Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

    About Roche

    Headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the 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 employs roughly 65,000 people in 150 countries. The Group has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

    All trademarks used or mentioned in this release are legally protected.

    Further information:

    - www.roche.com

    - www.gene.com

    - www.osip.com

    - www.health-kiosk.ch

    Reference:

    1. Shepherd, F.; A randomized placebo-controlled trial of erlotinib in patients with advanced non-small cell lung cancer (NSCLC) following failure of 1st line or or 2nd line chemotherapy. A National Cancer Institute of Canada Clinical Trials Group (NCIC). (Abstract #7022), ASCO 2004.

    2. World Health Organisation, World Cancer Report, 2003.

    3. www.lungcancercoalition.org/cancer_facts.html.

ots Originaltext: Roche Holding AG
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