Roche Pharmaceuticals

Roche Requests Re-Examination of CHMP Opinion on Tarceva in Pancreatic Cancer at the European Medicines Agency

Basel, Switzerland (ots/PRNewswire) - - First Treatment for Years to Have Shown a Significant Survival Benefit for Patients Roche announced today that it has requested a re-examination of the data supporting the filing of their breakthrough cancer medicine, Tarceva, for the treatment of pancreatic cancer following the recent negative opinion from the European Committee for Medicinal Products for Human Use (CHMP). The filing was specifically for the use of Tarceva (erlotinib) in combination with gemcitabine chemotherapy for the first line treatment of advanced pancreatic cancer. Pancreatic cancer is one of the most aggressive forms of cancer killing more people within the first year of diagnosis than any other cancer. (1) People with pancreatic cancer have limited treatment options and Tarceva is the first treatment for many years to have shown a significant survival benefit in patients with pancreatic cancer. "People with pancreatic cancer need new treatment options like Tarceva which has been proven in clinical trials to significantly increase survival and has already been approved for this indication in the US," said Eduard Holdener, Head of Global Drug Development. "In light of this, we are asking the CHMP to re-consider its opinion." Tarceva was granted a licence by the American FDA (Food and Drug Administration) in November 2005 for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine chemotherapy. Both the US and the EU license applications are based on data from the Phase III study (PA3)(2) which showed that treatment with Tarceva plus gemcitabine results in significantly longer survival (22%) compared to gemcitabine alone. 24% of patients receiving Tarceva plus gemcitabine were alive after one year, compared to 19% on gemcitabine alone. Roche and its partners are committed to realising the potential of Tarceva in treating pancreatic cancer through its extensive clinical trial programme, including a Roche-sponsored randomised, double blind, placebo controlled study of gemcitabine and Tarceva +/- Avastin in patients with metastatic pancreatic cancer (AVITA or BO17706). Tarceva is approved and marketed 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. A variation application was submitted to the European Health Authorities in October 2005 for Tarceva plus gemcitabine chemotherapy for the first-line treatment of patients with advanced pancreatic cancer. In April 2006, Chugai Pharmaceutical Co., Ltd. filed a New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare (MHLW) for Tarceva in patients with advanced or recurrent NSCLC. About the PA3 study(2) The pivotal Phase III randomised study (PA3)(2) of 569 patients was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University. The double blind study evaluated Tarceva's efficacy in patients with locally advanced or metastatic pancreatic cancer. The results of PA3(2) demonstrated the following: - Treatment with Tarceva plus gemcitabine in patients with advanced pancreatic cancer resulted in significantly longer survival compared to gemcitabine alone (22%) - 24% of patients receiving Tarceva plus gemcitabine were alive after one year, compared to 19% on gemcitabine alone - Patients receiving Tarceva plus gemcitabine experienced significantly longer progression-free survival of 30% - Tarceva plus gemcitabine was well tolerated by patients with no increase in haematological toxicity; expected rash and diarrhoea were the principal Tarceva-related side effects seen in the study and were generally characterised as mild-to-moderate - Tarceva plus gemcitabine reported a safety profile generally consistent with that seen in other studies both monotherapy and combination settings About pancreatic cancer Pancreatic cancer is the tenth most frequently occurring cancer in Europe.(3) The main risk factors for pancreatic cancer include advanced age, cigarette smoking, a high-fat diet, diabetes mellitus, chronic inflammation of the pancreas (pancreatitis), especially hereditary pancreatitis, and a family history of pancreatic cancer.(4) The symptoms vary depending upon where the tumour is in the pancreas. The major symptoms are weight loss, abdominal pain and jaundice. (1) The disease is rapidly fatal and attempts to improve survival over the past 10 years have been unsuccessful. About Tarceva Tarceva (erlotinib) is a 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 - a striking 42.5%. 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 EU for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva has been approved by the FDA since November 2, 2005 for the first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine chemotherapy. 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). 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 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 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. For further information about: - Cancer: www.health-kiosk.ch - Roche in Oncology: www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf - Genentech: www.gene.com - OSI Pharmaceuticals: www.osip.com References: 1. Steward, B W and Kleihues, P. 2003. World Cancer Report. World Health Organisation and the International Agency for Research on Cancer, IARC Press/Lyon, p248 2. Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A Phase III trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]. (Abstract #1, ASCO 2005) 3. De Braud F, Cascinu S, Gatta G. 2004, May. Cancer of Pancreas. Critical reviews in oncology/hematology, 50(2):147-55 4. Truninger K (ed). 2002, Aug. Risk groups for pancreatic and bile duct carcinomas. Schweizerische Rundschau fur Medizin Praxis, 17;89 (33):1299-304 ots Originaltext: Roche Pharmaceuticals Im Internet recherchierbar: http://www.presseportal.ch Contact: Media Contacts: Roche Group Media Office, Phone: +41-61-688-8888, e-mail: basel.mediaoffice@roche.com - Baschi Durr, - Alexander Klauser, - Daniel Piller (Head of Roche Group Media Office), - Katja Prowald (Head of R&D Communications), - Martina Rupp

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