Healthcare Industry News: sapropterin
News Release - June 1, 2009
UK's NICE Recommends Use of Erbitux for Metastatic Colorectal Cancer PatientsErbitux is the only 1st-line targeted therapy for mCRC recommended by NICE
Decision further endorses the role of personalizing cancer care and the importance of ‘tailoring’ treatment by tumor type at diagnosis
DARMSTADT, Germany--(HSMN NewsFeed)--The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has today published a Final Appraisal Determination (FAD) recommending the use of the drug Erbitux® (cetuximab) in combination with chemotherapy as a 1st-line treatment for patients with metastatic (advanced) colorectal cancer (mCRC) who have met specific additional criteria1 – presenting the possibility of potentially curative surgery.2 The treatment is recommended for patients in whom the cancer has spread only to the liver and who have normal or ‘wild-type’ KRAS tumors.1 In the UK, a recommendation by NICE is a prerequisite for funding of a medical treatment by the National Health Service.
The evidence supporting NICE’s decision includes the CRYSTALa study, published in the New England Journal of Medicine in April 2009, which demonstrated the efficacy of Erbitux in mCRC patients with KRAS wild-type tumors, representing up to 65% of patients3. The CELIMb study also supported the decision demonstrating that in KRAS wild-type patients, Erbitux plus chemotherapy achieved some of the highest response rates (shrinkage of tumor) observed in clinical trials. Because of this increase in response, mCRC patients with previously inoperable liver metastases were able to undergo liver surgery, thus increasing the potential for cure in four out of 10 patients in this setting.4
This followed the presentation at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) earlier this year of an abstract outlining the potential economic savings that could result from routinely testing mCRC patients for their KRAS status at diagnosis to determine who would be most likely to benefit from treatment with Erbitux.5
More than 370,000 people develop colorectal cancer in Europe every year, accounting for 13% of the total cancer burden and around 200,000 deaths.6 Approximately 25% of patients present with metastatic disease,7and 5-year survival rates for patients with mCRC can be as low as 5%.8
The final NICE guidance is scheduled to be published in July and will be implemented within three months of publication. The full NICE FAD for the use of Erbitux in treatment of advanced colorectal cancer can be found at www.nice.org.uk.
aCRYSTAL: Cetuximab combined with iRinotecan in first line therapY for metaSTatic colorectAL cancer
bCELIM: Randomized multicenter study of CEtuximab plus FOLFOX or FOLFIRI in neoadjuvant treatment of non-resectable colorectal LIver Metastases
1. National Institute for Health and Clinical Excellence. Final Appraisal Determination: Cetuximab for the first-line treatment of metastatic colorectal cancer. June 2009.
2. Folprecht G et al. Ann Oncol 2005;16:1311–131.
3. Van Cutsem E, et al. N Engl J Med 2009;360:1408-17.
4. Folprecht G et al. ASCO GI 2009. Abstract No: 296.
5. Shankaran V, et al. Data presented at ASCO GI Congress 2009; Abstract No: 298.
6. Parkin DM, et al. CA Cancer J Clin 2005;55:74-108.
7. Cunningham D & Findley M. Eur J Cancer 1993;29A(15):2077-9.
8. Macdonald JS. CA Cancer J Clin 1999;49(4):202-19.
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 76 countries. It has been approved for the treatment of colorectal cancer in 75 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 71 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 Systems, a wholly-owned subsidiary of Eli Lilly and Company, in 1998. In Japan, ImClone Systems, 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., 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, a global pharmaceutical and chemical group. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. Its North American business operates in the United States and Canada as EMD Serono.
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 around € 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 € 7.6 billion in 2008, a history that began in 1668, and a future shaped by 32,700 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 Serono
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