Magazin
2005-10-31
Basel, Switzerland (ots/PRNewswire) - The news that the innovativenew cancer drug Tarceva(R) (erlotinib) is now becoming availableacross the EU will provide a glimmer of hope to over 380,000 peoplein Europe this year who have received the devastating news that theyhave lung cancer.
Not only has Tarceva demonstrated a striking survival benefit(42.5 per cent) in advanced non-small cell lung cancer, the mostcommon form of the disease, it has also been shown to significantlyimprove patients' quality of life by alleviating the severe anddebilitating symptoms that characterise advanced disease, such ascough, pain and breathlessness.
June Sheldon, a 71 year old grandmother, was diagnosed withadvanced non-small cell lung cancer April 2002. "I could hardlybreathe before and didn't think I would last a year. I'm living proofof the benefit of taking Tarceva, I don't think I would be hereotherwise and it made a difference to my life much more quickly thanI thought," said June. "Now I go out for lunch two or three times aweek and wander around the shops, I really feel I can get on with mylife."
Physicians and patients are crying out for new lung cancertreatments as globally the disease is increasing at such an alarmingrate that it is often referred to as an epidemic.(1) The highestrates are seen in parts of Northern Europe but rates are rapidlyincreasing in most other parts of the world. Although incidencerates 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 ofchemotherapy agents in the last ten years," said Professor GiuseppeGiaccone, VU Medical Center, Amsterdam. "Tarceva is an excitingadvance in treatment. It offers a beacon of hope to physicians andpatients alike in an area that has long suffered from therapeuticscepticism."
Many people with advanced non-small cell lung cancer do notreceive chemotherapy. This can be for a variety of reasons but ismost 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 chemotherapybut, importantly, without compromising tolerability and overallquality of life.
"There is still a long way to go in the development of treatmentsfor lung cancer however, Tarceva is an important and exciting stepforward," said Dr Jesme Baird, of the patient advocacy organisationthe Roy Castle Lung Cancer Foundation in the UK. "It could reallyimprove the lives of people with lung cancer so they can enjoy timewith their family and friends and lead as normal a life as possible."
Beyond its devastating human cost, lung cancer also has a highfinancial cost on society both in terms of direct costs, such ashospital care, and indirect costs, such as working days lost. Theindirect cost of lung cancer is two to three times that of the directcost and is one of the most important in terms of working yearslost.(4) In Germany alone, 59,000 working years and 557,000 totalyears were lost in 2002 totalling 14.7 billion Euros(4) notincluding morbidity costs.
Tarceva Approval Based on Compelling Study Results
Tarceva is approved for locally advanced or metastatic non-smallcell lung cancer after failure of at least one prior chemotherapyregimen,
The EU approval was based on a pivotal Phase III study recentlypublished in the New England Journal of Medicine (NEJM). The studywas conducted by the National Cancer Institute of Canada ClinicalTrials Group based at Queen's University, in collaboration with OSIPharmaceuticals, with the participation of 86 sites from 17 countriesaround the world. This Phase III study (NCIC-CTG BR.21) involved 731patients with advanced non-small cell lung cancer (NSCLC) whosecancers had progressed after first- or second-line chemotherapy. Thestudy compared patients receiving Tarceva monotherapy with placebo.
The key study results were:
- Treatment with Tarceva in patients with advanced NSCLC resultedin 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 yearcompared to 22% in the placebo arm.
- Patients receiving Tarceva had stability or control of theirlung cancer-related symptoms such as cough, shortness of breath andpain, for significantly longer.
- Patients also had a superior quality of life and improvedphysical function compared to those on placebo.
- The benefits of Tarceva were shown in a broad spectrum ofpatients.
About Tarceva
Tarceva is an investigational small molecule that targets thehuman epidermal growth factor receptor (HER1) pathway. HER1, alsoknown as EGFR, is a key component of this signalling pathway, whichplays a role in the formation and growth of numerous cancers. Tarcevablocks tumour cell growth by inhibiting the tyrosine kinase activityof the HER1 signalling pathway inside the cell.
Taken as an oral, once-daily therapy, Tarceva is the onlyEGFR-inhibitor to have demonstrated a survival benefit in lungcancer. Currently most lung cancer patients are treated withchemotherapy which can be very debilitating due to its toxic nature.Tarceva works differently to chemotherapy by specifically targetingtumour cells, and avoids the typical side-effects of chemotherapy.
Tarceva is approved in the US and across the European Union forpatients with locally advanced or metastatic non-small cell lungcancer (NSCLC) after failure of at least one prior chemotherapyregimen.
Tarceva is currently being evaluated in an extensive clinicaldevelopment 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 inNSCLC. Trials are also being conducted with Tarceva in other solidtumours, 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 UnitedStates and Chugai in Japan, is the world's leading provider of cancercare products, including anti-cancer treatments, supportive careproducts and diagnostics. Its oncology business includes anunprecedented five products proven to provide survival benefit indifferent major tumour indications: Avastin, Herceptin, and Xeloda inadvanced-stage breast cancer, Herceptin in early-stage HER2-positivebreast cancer, MabThera in non-Hodgkin's lymphoma, Avastin and Xelodain colorectal cancer, Avastin and Tarceva in non-small cell lungcancer and Tarceva in pancreatic cancer.
In addition to these anti-cancer agents, the Roche oncologyportfolio includes a comprehensive collection of medicines that canhelp improve the quality of life of cancer patients: Bondronat (forprevention of skeletal events in patients with breast cancer and bonemetastases, hypercalcaemia of malignancy), Kytril (for chemotherapyand radiotherapy-induced nausea and vomiting), Neupogen (forcancer-related neutropenia), and NeoRecormon (for anaemia in variouscancer settings). CERA is the most recent demonstration of Roche'scommitment to anaemia management. Other oncology products includeFurtulon (for colorectal cancer) and Roferon-A (for hairy cell andchronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma,renal cell carcinoma). The Roche Group's cancer medicines generatedsales of more than 7.7 billion Swiss francs in 2004.
In addition to the medicines, Roche is developing new diagnostictests that will have a significant impact on disease management forcancer patients in the future. With a broad portfolio of tumourmarkers for prostate, colorectal, liver, ovarian, breast, stomach,pancreas and lung cancer, as well as a range of molecular oncologytests, Roche will continue to be the leader in providingcancer-focused treatments and diagnostics.
The unmatched Roche oncology portfolio as well as an extensiveexternal innovation base through collaborations with companies andacademia is what makes it possible for Roche to provide moreeffective cancer therapies.
In the United States Herceptin, MabThera (Rituxan), Avastin andTarceva are marketed either by Genentech alone or together with itspartners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside ofthe United States, Roche and its Japanese partner Chugai areresponsible for the marketing of these medicines.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As a supplier of innovative productsand services for the early detection, prevention, diagnosis andtreatment of disease, the Group contributes on a broad range offronts to improving people's health and quality of life. Roche is aworld leader in diagnostics, the leading supplier of medicines forcancer and transplantation and a market leader in virology. In 2004sales by the Pharmaceuticals Division totalled 21.7 billion Swissfrancs, while the Diagnostics Division posted sales of 7.8 billionSwiss francs. Roche employs roughly 65,000 people in 150 countriesand has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech andChugai. Additional information about the Roche Group is available onthe Internet (www.roche.com).
All trademarks used or mentioned in this release are legallyprotected.
References:
1. Wilking N and B Jonsson, A Pan European comparison regardingpatient access to cancer drug, Karolinska Institute and StockholmSchool of Economics, Stockholm, Sweden 2005, A - xv
2. Wilking N and B Jonsson, A Pan European comparison regardingpatient access to cancer drug, Karolinska Institute and StockholmSchool of Economics, Stockholm, Sweden 2005, p29
3. Wilking N and B Jonsson, A Pan European comparison regardingpatient access to cancer drug, Karolinska Institute and StockholmSchool of Economics, Stockholm, Sweden 2005, p91
4. Wilking N and B Jonsson, A Pan European comparison regardingpatient access to cancer drug, Karolinska Institute and StockholmSchool of Economics, Stockholm, Sweden 2005, p15
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:For further information please contact: Helen Bridges Resolute Communications +44-7815-297112
Innovative Drug Tarceva Now Available in Europe to Tackle Growing Lung Cancer Epidemic
Not only has Tarceva demonstrated a striking survival benefit(42.5 per cent) in advanced non-small cell lung cancer, the mostcommon form of the disease, it has also been shown to significantlyimprove patients' quality of life by alleviating the severe anddebilitating symptoms that characterise advanced disease, such ascough, pain and breathlessness.
June Sheldon, a 71 year old grandmother, was diagnosed withadvanced non-small cell lung cancer April 2002. "I could hardlybreathe before and didn't think I would last a year. I'm living proofof the benefit of taking Tarceva, I don't think I would be hereotherwise and it made a difference to my life much more quickly thanI thought," said June. "Now I go out for lunch two or three times aweek and wander around the shops, I really feel I can get on with mylife."
Physicians and patients are crying out for new lung cancertreatments as globally the disease is increasing at such an alarmingrate that it is often referred to as an epidemic.(1) The highestrates are seen in parts of Northern Europe but rates are rapidlyincreasing in most other parts of the world. Although incidencerates 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 ofchemotherapy agents in the last ten years," said Professor GiuseppeGiaccone, VU Medical Center, Amsterdam. "Tarceva is an excitingadvance in treatment. It offers a beacon of hope to physicians andpatients alike in an area that has long suffered from therapeuticscepticism."
Many people with advanced non-small cell lung cancer do notreceive chemotherapy. This can be for a variety of reasons but ismost 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 chemotherapybut, importantly, without compromising tolerability and overallquality of life.
"There is still a long way to go in the development of treatmentsfor lung cancer however, Tarceva is an important and exciting stepforward," said Dr Jesme Baird, of the patient advocacy organisationthe Roy Castle Lung Cancer Foundation in the UK. "It could reallyimprove the lives of people with lung cancer so they can enjoy timewith their family and friends and lead as normal a life as possible."
Beyond its devastating human cost, lung cancer also has a highfinancial cost on society both in terms of direct costs, such ashospital care, and indirect costs, such as working days lost. Theindirect cost of lung cancer is two to three times that of the directcost and is one of the most important in terms of working yearslost.(4) In Germany alone, 59,000 working years and 557,000 totalyears were lost in 2002 totalling 14.7 billion Euros(4) notincluding morbidity costs.
Tarceva Approval Based on Compelling Study Results
Tarceva is approved for locally advanced or metastatic non-smallcell lung cancer after failure of at least one prior chemotherapyregimen,
The EU approval was based on a pivotal Phase III study recentlypublished in the New England Journal of Medicine (NEJM). The studywas conducted by the National Cancer Institute of Canada ClinicalTrials Group based at Queen's University, in collaboration with OSIPharmaceuticals, with the participation of 86 sites from 17 countriesaround the world. This Phase III study (NCIC-CTG BR.21) involved 731patients with advanced non-small cell lung cancer (NSCLC) whosecancers had progressed after first- or second-line chemotherapy. Thestudy compared patients receiving Tarceva monotherapy with placebo.
The key study results were:
- Treatment with Tarceva in patients with advanced NSCLC resultedin 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 yearcompared to 22% in the placebo arm.
- Patients receiving Tarceva had stability or control of theirlung cancer-related symptoms such as cough, shortness of breath andpain, for significantly longer.
- Patients also had a superior quality of life and improvedphysical function compared to those on placebo.
- The benefits of Tarceva were shown in a broad spectrum ofpatients.
About Tarceva
Tarceva is an investigational small molecule that targets thehuman epidermal growth factor receptor (HER1) pathway. HER1, alsoknown as EGFR, is a key component of this signalling pathway, whichplays a role in the formation and growth of numerous cancers. Tarcevablocks tumour cell growth by inhibiting the tyrosine kinase activityof the HER1 signalling pathway inside the cell.
Taken as an oral, once-daily therapy, Tarceva is the onlyEGFR-inhibitor to have demonstrated a survival benefit in lungcancer. Currently most lung cancer patients are treated withchemotherapy which can be very debilitating due to its toxic nature.Tarceva works differently to chemotherapy by specifically targetingtumour cells, and avoids the typical side-effects of chemotherapy.
Tarceva is approved in the US and across the European Union forpatients with locally advanced or metastatic non-small cell lungcancer (NSCLC) after failure of at least one prior chemotherapyregimen.
Tarceva is currently being evaluated in an extensive clinicaldevelopment 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 inNSCLC. Trials are also being conducted with Tarceva in other solidtumours, 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 UnitedStates and Chugai in Japan, is the world's leading provider of cancercare products, including anti-cancer treatments, supportive careproducts and diagnostics. Its oncology business includes anunprecedented five products proven to provide survival benefit indifferent major tumour indications: Avastin, Herceptin, and Xeloda inadvanced-stage breast cancer, Herceptin in early-stage HER2-positivebreast cancer, MabThera in non-Hodgkin's lymphoma, Avastin and Xelodain colorectal cancer, Avastin and Tarceva in non-small cell lungcancer and Tarceva in pancreatic cancer.
In addition to these anti-cancer agents, the Roche oncologyportfolio includes a comprehensive collection of medicines that canhelp improve the quality of life of cancer patients: Bondronat (forprevention of skeletal events in patients with breast cancer and bonemetastases, hypercalcaemia of malignancy), Kytril (for chemotherapyand radiotherapy-induced nausea and vomiting), Neupogen (forcancer-related neutropenia), and NeoRecormon (for anaemia in variouscancer settings). CERA is the most recent demonstration of Roche'scommitment to anaemia management. Other oncology products includeFurtulon (for colorectal cancer) and Roferon-A (for hairy cell andchronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma,renal cell carcinoma). The Roche Group's cancer medicines generatedsales of more than 7.7 billion Swiss francs in 2004.
In addition to the medicines, Roche is developing new diagnostictests that will have a significant impact on disease management forcancer patients in the future. With a broad portfolio of tumourmarkers for prostate, colorectal, liver, ovarian, breast, stomach,pancreas and lung cancer, as well as a range of molecular oncologytests, Roche will continue to be the leader in providingcancer-focused treatments and diagnostics.
The unmatched Roche oncology portfolio as well as an extensiveexternal innovation base through collaborations with companies andacademia is what makes it possible for Roche to provide moreeffective cancer therapies.
In the United States Herceptin, MabThera (Rituxan), Avastin andTarceva are marketed either by Genentech alone or together with itspartners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside ofthe United States, Roche and its Japanese partner Chugai areresponsible for the marketing of these medicines.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As a supplier of innovative productsand services for the early detection, prevention, diagnosis andtreatment of disease, the Group contributes on a broad range offronts to improving people's health and quality of life. Roche is aworld leader in diagnostics, the leading supplier of medicines forcancer and transplantation and a market leader in virology. In 2004sales by the Pharmaceuticals Division totalled 21.7 billion Swissfrancs, while the Diagnostics Division posted sales of 7.8 billionSwiss francs. Roche employs roughly 65,000 people in 150 countriesand has R&D agreements and strategic alliances with numerouspartners, including majority ownership interests in Genentech andChugai. Additional information about the Roche Group is available onthe Internet (www.roche.com).
All trademarks used or mentioned in this release are legallyprotected.
References:
1. Wilking N and B Jonsson, A Pan European comparison regardingpatient access to cancer drug, Karolinska Institute and StockholmSchool of Economics, Stockholm, Sweden 2005, A - xv
2. Wilking N and B Jonsson, A Pan European comparison regardingpatient access to cancer drug, Karolinska Institute and StockholmSchool of Economics, Stockholm, Sweden 2005, p29
3. Wilking N and B Jonsson, A Pan European comparison regardingpatient access to cancer drug, Karolinska Institute and StockholmSchool of Economics, Stockholm, Sweden 2005, p91
4. Wilking N and B Jonsson, A Pan European comparison regardingpatient access to cancer drug, Karolinska Institute and StockholmSchool of Economics, Stockholm, Sweden 2005, p15
ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
Contact:For further information please contact: Helen Bridges Resolute Communications +44-7815-297112
Roche Pharmaceuticals
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