Tarceva : European Approval For Pancreatic Cancer Treatment

Roche's innovative cancer drug Tarceva (erlotinib), has been approved today by the European Commission for the treatment of patients with metastatic pancreatic cancer, in combination with a standard chemotherapy, gemcitabine. Tarceva is the first treatment in over a decade to have shown a significant survival benefit in treating patients with this devastating disease. Pancreatic cancer has the highest one-year mortality rate of any cancer and is Europe's sixth deadliest cancer.1

"This is a much needed treatment advance for patients suffering with this difficult-to-treat disease," said William M. Burns, CEO Roche Pharmaceuticals. "The approval of Tarceva in combination with gemcitabine chemotherapy offers patients and their families some real hope."

The approval was based on data from the pivotal PA.3 Phase III Study,2 which show that for patients with metastatic disease, treatment with Tarceva plus gemcitabine results in significantly longer survival (25 percent) compared to gemcitabine alone. In addition, a higher percentage of these patients were alive at 12 months in the group treated with Tarceva plus gemcitabine, compared to those treated with chemotherapy alone (21 percent v. 15 percent). The approval follows a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) in December 2006.

Pancreatic cancer is the sixth most frequently occurring cancer in Europe.1 In 2002, there were more than 78,000 new cases of pancreatic cancer diagnosed in Europe, with a death rate of approximately 82,000 people per year. 3 Pancreatic cancer is difficult to treat as it is often resistant to chemotherapy and radiotherapy and tends to spread quickly to other parts of the body, leading to a short life expectancy.

"Tarceva generates renewed optimism for patients and physicians," said Professor Eric Van Cutsem, of the University Hospital of Gasthuisberg, Belgium. "This approval marks a clear step forward in providing them with another treatment option for battling this terrible disease."

About the PA32 study

The results of the double-blind, placebo-controlled Phase III study conducted by the National Cancer Institute of Canada, Clinical Trials Group at Queens University and involving 569 patients showed:

-- Treatment with Tarceva plus gemcitabine in patients with metastatic pancreatic cancer resulted in significantly improved overall survival compared to gemcitabine alone (25%)

-- 21% of these patients receiving Tarceva plus gemcitabine were alive after one year, compared to 15% on gemcitabine alone

-- Overall, patients receiving Tarceva plus gemcitabine experienced significantly longer progression-free survival of 30%

-- Tarceva plus gemcitabine was generally well tolerated by patients

Tarceva plus gemcitabine is already approved for the treatment of locally advanced, unresectable or metastatic pancreatic cancer in 15 countries including America and Australia. 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.

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 and pancreatic cancer. Currently most lung and pancreatic cancer patients are treated wholly 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. It is also approved in the US for the first-line treatment of patients with 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 and in a wide variety of other solid tumour types.

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. 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 (http://www.roche.com).

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References

1) Michaud DS. 2004. Epidemiology of pancreatic cancer Minerva Chir. Apr; 59(2):99-111
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) Ferlay J et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No. 5, Version 2.0, Lyon; IARC Press 2004

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