Approximately half of patients with mCRC have RAS wild-type tumors and half have RAS mutant tumors.1 Results from studies assessing RAS mutation status in patients with mCRC have shown that anti-epidermal growth factor receptor (EGFR) monoclonal antibody therapies, such as Erbitux® (cetuximab), can improve outcomes in patients with RAS wild-type mCRC.2–6 Colorectal cancer (CRC) is the third most common cancer worldwide, with an estimated incidence of more than 1.36 million new cases annually.7 An estimated 694,000 deaths from CRC occur worldwide every year, accounting for 8.5% of all cancer deaths and making it the fourth most common cause of death from cancer.7 Almost 55% of CRC cases are diagnosed in developed regions of the world, and incidence and mortality rates are substantially higher in men than in women.7
- Vaughn CP, et al. Genes Chromosomes Cancer. 2011;50(5):307−12.
- Douillard J-Y, et al. N Engl J Med 2013;369(11):1023–34.
- Schwartzberg LS, et al. J Clin Oncol 2014; March 31 [Epub ahead of print]. Available online: http://www.ncbi.nlm.nih.gov/pubmed/24687833. Last accessed January 2016.
- Bokemeyer C, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30–June 3, 2014.
- Stintzing S, et al. European Cancer Congress 2013:Abstract No:LBA17.
- Ciardiello F, et al. Oral presentation at the 2014 American Society of Clinical Oncology Annual Meeting, May 30–June 3, 2014.
- Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available at: http://globocan.iarc.fr. Last accessed January 2016.
Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis’ proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Idylla™ addresses the growing demand for personalized medicine by aiming to allow fast and effective treatment selection and treatment progress monitoring. Biocartis launched the Idylla™ platform commercially in September 2014 together with its first assay to identify BRAF Mutations in metastatic melanoma. Its second assay, a KRAS Mutation panel for colorectal cancer, was launched in June 2015. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Further information can be found at: www.biocartis.com.
Idylla™, Biocartis’ fully automated, real-time PCR based molecular diagnostics system, is designed to offer fast and easy access to clinical molecular diagnostic information, anywhere and anytime. The Idylla™ platform covers the entire process from sample to result in a time frame of 35 to 150 minutes with less than two minutes hands-on time. Idylla™ is applicable for a wide range of clinical sample types and can analyze both RNA and DNA. The fully integrated system enables clinical laboratories to perform a broad range of applications in oncology, infectious diseases and beyond. The Idylla™ system’s first diagnostic tests, the Idylla™ BRAF Mutation Test for metastatic melanoma, the Idylla™ KRAS Mutation Test for colorectal cancer and the first infectious disease test, the Idylla™ Respiratory (IFV-RSV) Panel developed in collaboration with Janssen Diagnostics, have obtained CE-IVD marking. Further information can be found at: www.idylla.com.
Erbitux® is a 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 over 90 countries world-wide for the treatment of colorectal cancer and for the treatment of squamous cell carcinoma of the head and neck (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. Merck has an ongoing commitment to the advancement of oncology treatment and is currently investigating novel therapies in highly targeted areas.
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Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck KGaA, Darmstadt, Germany, generated sales of € 12.85 billion in 66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, holds the global rights to the „Merck” name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.