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News In Europe Re: Tarceva


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Tarceva (Erlotinib) Receives Positive EU Opinion for Treatment of Metastatic Pancreatic Cancer

BASEL, SWITZERLAND -- December 18, 2006 -- Roche announced today that its oral cancer medicine Tarceva (erlotinib) has received a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) following a re-examination of the data supporting the filing of Tarceva in metastatic pancreatic cancer. Tarceva is the first treatment in over a decade to have shown a significant survival benefit in patients with this devastating disease where the five year survival rate has not changed in decades and remains at less than five percent (1, 2).

Tarceva has already been approved by the American Food and Drug Administration (FDA) in November 2005 and in a further 15 countries around the world for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine chemotherapy.

"News of the CHMP opinion will be welcomed by pancreatic cancer patients across the EU as it widens previously limited treatment options," said Eduard Holdener, Head of Global Drug Development. "The success of Tarceva in combination with gemcitabine chemotherapy is an important step forward in the struggle against this devastating disease."

Both the non-EU and the EU applications were based on data from the Phase III study (PA3) (3) which show that treatment with Tarceva plus gemcitabine results in significantly longer survival (22 percent) compared to gemcitabine alone. In addition, a higher percentage of patients were alive at 12 months in the group treated with Tarceva plus gemcitabine, compared to those treated with chemotherapy alone (24 percent v. 19 percent).

Pancreatic cancer is the tenth most frequently occurring cancer in Europe (4). 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 (5). 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 its high mortality and short life expectancy. Tarceva is the first treatment for many years to have shown a significant survival benefit in patients with pancreatic cancer.

About the PA3 (3) 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 advanced pancreatic cancer resulted in significantly improved overall 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

As a result of this study, Tarceva plus gemcitabine has been approved for the treatment of advanced pancreatic cancer in 15 countries including America and Australia.

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 very impressive 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 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 has been approved by the FDA since November 2, 2005 for treatment of locally advanced, inoperable, 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.

Additional information

- About Roche: www.roche.com

- About Genentech: www.gene.com

- About OSI: www.osip.com

- About cancer: www.health-kiosk.ch

- Roche in Oncology: http://www.roche.com/pages/downloads/co ... ogy05e.pdf


(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) Khosravi Shahi P et al. 2005, Aug. Pancreatic cancer: therapeutic update. Anales de medna interna, 22 (8):390-4

(3) 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)

(4) De Braud F, Cascinu S, Gatta G. 2004, May. Cancer of Pancreas. Critical reviews in oncology/hematology, 50(2):147-55

(5) Ferlay J et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No. 5, Version 2.0, Lyon; IARC Press 2004

SOURCE: F. Hoffmann-La Roche Ltd

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