Merck KGaA Submits New License Application for Erbitux in Firstline Non-Small Cell Lung Cancer in Europe
DARMSTADT, Germany, Sept. 11, 2008 - Merck KGaA announced today that its Merck Serono division has submitted an application to the European Medicines Agency (EMEA) to license Erbitux (cetuximab) for the firstline treatment of epidermal growth factor receptor (EGFR) expressing, advanced or metastatic non-small cell lung cancer (NSCLC).
The submission is supported by data from the Phase III FLEXa study presented this year at the plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting. The study demonstrated a significant increase in overall survival for patients receiving Erbitux in combination with a platinum-based chemotherapy as a firstline treatment for advanced NSCLC.(1)
"Erbitux represents the first significant and clinically relevant advance in 10 years in the treatment of such a broad patient population in NSCLC," said Dr Wolfgang Wein, Executive Vice President, Oncology, Merck Serono. "If approved in NSCLC Erbitux would not only provide physicians with a new important option for the therapy of this aggressive and difficult-to-treat cancer, it will also enable a greater number of cancer patients in Europe to benefit from treatment with Erbitux."
Erbitux is already licensed in the European Union for all lines of treatment for patients with EGFR-expressing, KRAS wild-type metastatic colorectal cancer (mCRC) in combination with chemotherapy, and as a single agent for patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. Erbitux is also licensed in combination with radiotherapy for locally advanced squamous cell carcinoma of the head and neck (SCCHN). In addition, Merck Serono submitted an application to the EMEA in June 2008 to broaden the use of Erbitux to include firstline treatment of recurrent and/or metastatic SCCHN.
Lung cancer is the most common cause of cancer death in men worldwide and the second most common in women (after breast cancer).(2) Approximately 975,000 men and 376,000 women die from the disease each year.(3) Around 80% of lung cancer patients present with NSCLC (4) and approximately one-third of these patients' tumors already have advanced to the stage where surgical resection is not a viable option.(5) The outlook for lung cancer patients is poor with an overall five-year survival rate of approximately 10%, which compares unfavorably with the rates associated with other tumor types such as melanoma (81%) or breast cancer (75%).(6)
a. FLEX: First-line in Lung cancer with ErbituX
References
(1) Pirker, R et al. J Clin Oncol 2008; 26 (May 20 suppl; abstract 3).
(2) World Health Organization. Fact sheet N°297: Cancer. Last accessed on 4 August 2008.
(3) Global Cancer Facts & Figures 2007, American Cancer Society.
(4) D'Addario G & Felip E. Ann Oncol 2008;19 Suppl 2:ii39-40.
(5) Bayman NA, et al. Clin Lung Cancer 2008;9(2):92-101.
(6) Sant M, et al. Ann Oncol 2003;14 Suppl 5:v61-118.
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, the European Union, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Israel, Japan, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldavia, 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. 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, Japan, Lebanon, Mexico, Moldavia, New Zealand, Nicaragua, Panama, Peru, the Philippines, Russia, Singapore, Thailand, the US, and Venezuela. 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.
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 68 countries: Argentina, Australia, Belarus, Brazil, Chile, Colombia, Costa Rica, Croatia, El Salvador, the European Union, Guatemala, Hong Kong, Iceland, India, Indonesia, Israel, Kazakhstan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mexico, Moldavia, 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, Moldavia, 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, upon approval, 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.