Merck KGaA and its division Merck Serono announced today that they have received a positive opinion from the CHMP to extend the use of the targeted therapy Erbitux® (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)
Darmstadt, Germany | October 24, 2008 | Merck KGaA and its division Merck Serono announced today that they have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), to extend the use of the targeted therapy Erbitux® (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
The submission to the EMEA was supported by the results of the EXTREME study¹ – ErbituX in first-line Treatment of REcurrent or MEtastatic head and neck cancer – which was published recently in the renowned New England Journal of Medicine.¹ The study investigated the efficacy of Erbitux in combination with platinum-based chemotherapy in first-line treatment of recurrent and/or metastatic SCCHN.
The EXTREME study demonstrated that adding Erbitux to platinum-based chemotherapy significantly prolongs patients’ lives. Overall survival time increased from 7.4 to 10.1 months when Erbitux was added to standard platinum-based chemotherapy. This is the first regimen to show a survival benefit in 30 years.
“The positive opinion we received for Erbitux in the first-line treatment of recurrent and/or metastatic SCCHN is very good news. It draws us closer to obtaining approval and advancing the broader use and patient benefit of Erbitux across various tumor types. SCCHN is typically a difficult cancer to treat and Erbitux will provide the only advance in treatment options in 30 years for this patient population,” said Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono.
Erbitux is already approved in combination with radiotherapy for locally advanced disease. The results of the EXTREME study supported the application to extend the Erbitux label in combination with platinum-based chemotherapy for recurrent and/or metastatic disease. The application was submitted in June 2008.
In Europe alone, it is estimated that there are around 143,000 cases of head and neck cancer, and more than 68,000 deaths due to the disease, each year.2 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN.3 Head and neck cancer is the sixth most frequently occurring cancer worldwide4 and includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinus, and other sites located in the head and neck area. About 90% of head and neck cancers are of the squamous cell variety5 and nearly all express the epidermal growth factor receptor (EGFR), which is critical for tumor growth.6 Although there have been significant improvements in chemotherapy and surgical techniques, the disease is particularly challenging to treat since most patients present with advanced disease and often have secondary tumors, in addition to suffering from other co-morbidities.7 At least 75% of all head and neck cancers are attributed to its two major risk factors, smoking and alcohol consumption.8
References
1. Vermorken JB, et al. N Engl J Med 2008;359:1116-27.
2. GLOBOCAN 2002 (www-dep.iarc.fr), accessed October 2008.
3. Lefebvre J-L. Ann Oncol 2005;16(Suppl 6):vi7-vi12.
4. Hunter KD, et al. Nat Rev Cancer 2005;Feb;5(2):127-35.
5. Vermorken J. Ann Oncol 2005;16(Suppl 2):ii258-ii264.
6. Grandis JR & Tweardy DJ. Cancer Res 1993;53(15):3579-84.
7. Forastiere A, et al. N Engl J Med 2001;345(26):1890-1900.
8. Hashibe M, et al. J Natl Inst 2007;99:777-89.
For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: www.globalcancernews.com.
About Erbitux
Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.
The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.
Erbitux has already obtained market authorization in 75 countries. It has been approved for the treatment of colorectal cancer in 74 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Japan, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, the US, and Venezuela for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. In the European Union, the license was updated in July 2008 for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC (metastatic colorectal cancer) in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Apart from the European Union label, Erbitux is also approved for single-agent use in: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Iceland, Japan, Lebanon, Liechtenstein, Mexico, Moldova, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Russia, Singapore, Thailand, the US, and Venezuela.
In addition, Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in 69 countries: Argentina, Australia, Belarus, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Moldova, Nicaragua, Peru, the Philippines, Russia, and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.
Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, ImClone Systems Incorporated, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas, such as the use of Erbitux in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also acquired the rights for the cancer treatment UFT® (tegafur-uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.
Merck is also investigating among other cancer treatments the use of Stimuvax® (formerly referred to as BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Bellevue, Washington, USA.
Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,946 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
SOURCE: Merck KGaA
Post Views: 53
Merck KGaA and its division Merck Serono announced today that they have received a positive opinion from the CHMP to extend the use of the targeted therapy Erbitux® (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)
Darmstadt, Germany | October 24, 2008 | Merck KGaA and its division Merck Serono announced today that they have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), to extend the use of the targeted therapy Erbitux® (cetuximab) to include first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).
The submission to the EMEA was supported by the results of the EXTREME study¹ – ErbituX in first-line Treatment of REcurrent or MEtastatic head and neck cancer – which was published recently in the renowned New England Journal of Medicine.¹ The study investigated the efficacy of Erbitux in combination with platinum-based chemotherapy in first-line treatment of recurrent and/or metastatic SCCHN.
The EXTREME study demonstrated that adding Erbitux to platinum-based chemotherapy significantly prolongs patients’ lives. Overall survival time increased from 7.4 to 10.1 months when Erbitux was added to standard platinum-based chemotherapy. This is the first regimen to show a survival benefit in 30 years.
“The positive opinion we received for Erbitux in the first-line treatment of recurrent and/or metastatic SCCHN is very good news. It draws us closer to obtaining approval and advancing the broader use and patient benefit of Erbitux across various tumor types. SCCHN is typically a difficult cancer to treat and Erbitux will provide the only advance in treatment options in 30 years for this patient population,” said Dr. Wolfgang Wein, Executive Vice President, Oncology, Merck Serono.
Erbitux is already approved in combination with radiotherapy for locally advanced disease. The results of the EXTREME study supported the application to extend the Erbitux label in combination with platinum-based chemotherapy for recurrent and/or metastatic disease. The application was submitted in June 2008.
In Europe alone, it is estimated that there are around 143,000 cases of head and neck cancer, and more than 68,000 deaths due to the disease, each year.2 About 40% of patients with head and neck cancer have recurrent and/or metastatic SCCHN.3 Head and neck cancer is the sixth most frequently occurring cancer worldwide4 and includes cancers of the tongue, mouth, salivary glands, pharynx, larynx, sinus, and other sites located in the head and neck area. About 90% of head and neck cancers are of the squamous cell variety5 and nearly all express the epidermal growth factor receptor (EGFR), which is critical for tumor growth.6 Although there have been significant improvements in chemotherapy and surgical techniques, the disease is particularly challenging to treat since most patients present with advanced disease and often have secondary tumors, in addition to suffering from other co-morbidities.7 At least 75% of all head and neck cancers are attributed to its two major risk factors, smoking and alcohol consumption.8
References
1. Vermorken JB, et al. N Engl J Med 2008;359:1116-27.
2. GLOBOCAN 2002 (www-dep.iarc.fr), accessed October 2008.
3. Lefebvre J-L. Ann Oncol 2005;16(Suppl 6):vi7-vi12.
4. Hunter KD, et al. Nat Rev Cancer 2005;Feb;5(2):127-35.
5. Vermorken J. Ann Oncol 2005;16(Suppl 2):ii258-ii264.
6. Grandis JR & Tweardy DJ. Cancer Res 1993;53(15):3579-84.
7. Forastiere A, et al. N Engl J Med 2001;345(26):1890-1900.
8. Hashibe M, et al. J Natl Inst 2007;99:777-89.
For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: www.globalcancernews.com.
About Erbitux
Erbitux® is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR). As a monoclonal antibody, the mode of action of Erbitux is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. This binding inhibits the activation of the receptor and the subsequent signal-transduction pathway, which results in reducing both the invasion of normal tissues by tumor cells and the spread of tumors to new sites. It is also believed to inhibit the ability of tumor cells to repair the damage caused by chemotherapy and radiotherapy and to inhibit the formation of new blood vessels inside tumors, which appears to lead to an overall suppression of tumor growth.
The most commonly reported side effect with Erbitux is an acne-like skin rash that seems to be correlated with a good response to therapy. In approximately 5% of patients, hypersensitivity reactions may occur during treatment with Erbitux; about half of these reactions are severe.
Erbitux has already obtained market authorization in 75 countries. It has been approved for the treatment of colorectal cancer in 74 countries so far: Argentina, Australia, Belarus, Canada, Chile, China, Colombia, Costa Rica, Croatia, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Japan, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, the US, and Venezuela for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy. In the European Union, the license was updated in July 2008 for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC (metastatic colorectal cancer) in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Apart from the European Union label, Erbitux is also approved for single-agent use in: Argentina, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Iceland, Japan, Lebanon, Liechtenstein, Mexico, Moldova, New Zealand, Nicaragua, Norway, Panama, Peru, the Philippines, Russia, Singapore, Thailand, the US, and Venezuela.
In addition, Erbitux in combination with radiotherapy has been approved for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN) in 69 countries: Argentina, Australia, Belarus, Brazil, Canada, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldova, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, the Philippines, Qatar, Russia, Serbia, Singapore, South Africa, South Korea, Switzerland, Taiwan, Ukraine, Uruguay, the US, and Venezuela. In Argentina, Chile, Costa Rica, El Salvador, Guatemala, Hong Kong, Israel, Lebanon, Mexico, Moldova, Nicaragua, Peru, the Philippines, Russia, and the US, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.
Merck licensed the right to market Erbitux outside the US and Canada from ImClone Systems Incorporated of New York in 1998. In Japan, ImClone Systems Incorporated, Bristol-Myers Squibb Company and Merck jointly develop and commercialize Erbitux. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas, such as the use of Erbitux in colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer. Merck has also acquired the rights for the cancer treatment UFT® (tegafur-uracil) – an oral chemotherapy administered with folinic acid (FA) for the first-line treatment of metastatic colorectal cancer.
Merck is also investigating among other cancer treatments the use of Stimuvax® (formerly referred to as BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Bellevue, Washington, USA.
Merck is a global pharmaceutical and chemical company with total revenues of € 7.1 billion in 2007, a history that began in 1668, and a future shaped by 31,946 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.
SOURCE: Merck KGaA
Post Views: 53
