Healthcare Industry News: sapropterin
News Release - March 29, 2010
Merck Serono: Erbitux Granted Extended Use in Japan for 1st-Line Treatment of mCRC Patients with KRAS Wild-Type TumorsApproval of change in product information is based on the data of the Phase III CRYSTAL trial
DARMSTADT, Germany--(HSMN NewsFeed)--Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that Erbitux® (cetuximab) can now be used in Japan in combination with chemotherapy in the 1st-line treatment for patients with epidermal growth factor receptor (EGFR)-expressing, curatively unresectable (inoperable), advanced or recurrent colorectal cancer (mCRC) carrying the KRAS wildtype gene. This development is due to a change in the Japanese product information for Erbitux.1
The approval of this extended usage for Erbitux was granted following submission of data from the Phase III CRYSTALa trial to Japan’s Pharmaceutical and Medical Devices Agency (PMDA).
Updated data of CRYSTAL were presented at the American Society of Clinical Oncology’s 2010 Gastrointestinal Cancers Symposium (ASCO-GI) supporting the value of Erbitux in the 1st-line therapy of mCRC patients with KRAS wild-type tumors. They demonstrated a significant overall survival advantage for patients who were treated with Erbitux in combination with FOLFIRI compared to those who received chemotherapy alone. In addition, the updated analysis showed that the combination of Erbitux and FOLFIRI also significantly reduced the risk of disease progression by 30% (HR 0.696; p=0.0012) and increased the tumor response rate (RR 57.3% vs. 39.7%; p<0.0001) compared to chemotherapy alone.2
“The striking improvement in response rates seen in patients treated with Erbitux added to chemotherapy is of vital importance in Japan. High response rates mean significant tumor shrinkage, and studies show that this leads to increased opportunities for complete removal of the tumor and a higher potential for the disease to be cured,” said Wayne Paterson, Managing Director of Merck Serono Co., Ltd, Japan. “This is of particular value in a country where cure rather than palliation is a primary treatment objective.”
In Japan, Merck Serono began marketing Erbitux as a treatment of curatively unresectable, advanced/recurrent colorectal cancer on September 19, 2008. The development of Erbitux in Japan was based on a collaborative effort between Merck KGaA, ImClone LLC (a wholly-owned subsidiary of Eli Lilly & Co.), Bristol-Myers Squibb Company, Merck Serono Co., Ltd. Japan and Bristol-Myers K.K. Merck receives 50% of the profit or loss from sales in Japan whereas ImClone and Bristol-Myers Squibb each receive 25% of the profit or loss from sales in Japan.
The incidence of colorectal cancer in Japan has increased nearly five-fold in the last 25 years, mainly due to westernization of the diet.3 With more than 95,000 new cases reported in Japan in 2002, it has become the most common cancer among women and the second most common among men, after stomach cancer.4
aCRYSTAL: Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer
1 Erbitux Label, Japan
2 Van Cutsem E, et al. ASCO GI Congress 2010. Abstract No: 281.
3 Okuno K. Dig Surg 2007;24:108-14.
4 GLOBOCAN 2002. Available at: www-dep.iarc.fr/
For more information on Erbitux in colorectal, head & neck and non-small cell lung cancer, please visit: www.globalcancernews.com.
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 79 countries. It has been approved for the treatment of colorectal cancer in 79 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 76 countries:
* December 2003 (Switzerland), February 2004 (USA), June 2004 (EU) and followed by other countries: for use in combination with irinotecan in patients with EGFR-expressing mCRC (metastatic colorectal cancer) who have failed prior irinotecan therapy. In addition, Erbitux is also approved for single-agent use in further countries.
* April 2006 (EU) and followed by other countries: for use in combination with radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). In further countries, Erbitux is also approved as monotherapy in patients with recurrent and/or metastatic SCCHN who failed prior chemotherapy.
* July 2008 (EU): license was updated for the treatment of patients with epidermal growth factor receptor (EGFR) expressing, KRAS wild-type mCRC 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.
* July 2008 (Japan): for use in combination with irinotecan in patients with EGFR-expressing mCRC who have failed prior irinotecan therapy
* In November 2008 (EU): license was updated for the use in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN
Merck licensed the right to market Erbitux outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone, 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 and breast cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Oncothyreon Inc., Seattle, Washington, USA.
In addition, Merck is developing cilengitide, which is the first in a new class of investigational anti-cancer therapies called integrin inhibitors to reach Phase III of development; it is currently being investigated for the treatment of glioblastoma, SCCHN and NSCLC. Integrin inhibitors are thought to work by targeting the tumor and its vasculature.
About Merck Serono
Merck Serono is the division for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. In the United States and Canada, EMD Serono operates through separately incorporated affiliates.
Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alpha), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride) as well as cardiometabolic diseases (Glucophage®, metformin), Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.
With an annual R&D expenditure of more than € 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in autoimmune and inflammatory diseases.
For more information, please visit www.merckserono.com or www.merck.de
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Merck is a global pharmaceutical and chemical company with total revenues of € 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 33,000 employees in 61 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 Serono
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