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Disease background

   Global incidence and burden

  • Colorectal cancer (CRC) is a leading cause of cancer-related mortality1,2
  • CRC is the third most frequently diagnosed malignancy and the second highest leading cause of cancer-related deaths globally1,2
  • The global burden of CRC is rising, and since 2022 is expected to increase by over 85% by 2050, with around 3.5 million projected cases3

   Geographical variation

  • CRC incidence varies widely (up to 10-fold) and is highest in countries with a ‘high’ or ‘very high’ Human Development Index1,2
  • Modifiable environmental risk factors, such as obesity, physical inactivity, poor diet, alcohol, and tobacco use, contribute to the majority of CRC cases4

   Global incidence and burden

  • In 2020, squamous cell carcinoma of the head and neck (SCCHN) was the sixth most common cancer worldwide, with approximately 800,000
    annual cases5
  • The incidence of SCCHN is expected to rise by up to 20% in 20305
  • SCCHN represents 90% of head and neck cancer6

   Geographical variation

  • Lifestyle and cultural factors (such as betel nut chewing) play a role in the varying rates of different SCCHN localizations across
    geographical regions6–10
  • Tobacco smoking, especially when combined with alcohol consumption, is a major risk factor for head and neck cancer, while betel nut chewing is a significant risk factor in Southeast Asian countries and among Southeast Asian minority ethnic groups6
  • HPV infection is a major risk factor specifically for oropharyngeal cancer6-10

History of Cetuximab

The monoclonal antibody C225, that would later be known as cetuximab, was first identified in 1983.21,22 The timeline below provides a summary of key clinical trial and approval milestones for cetuximab, which changed the treatment landscape in CRC and SCCHN.

 

 

 

 

*In the EU, encorafenib is approved in combination with cetuximab for the ≥2L treatment of BRAF mt mCRC;

 

†In Japan, encorafenib is approved in combination with cetuximab ± binimetinib for the ≥2L treatment of BRAF mt mCRC, but the triplet combination is not approved in other countries. The BEACON study was not sponsored by Merck KGaA;

 

‡Encorafenib is approved in combination with cetuximab and mFOLFOX6 for treatment-naïve BRAF V600E mt mCRC in some countries including the US. However, this combination is not currently approved in the EU. The BREAKWATER study was not sponsored by Merck KGaA;

 

Approval information accurate as of January 2026.

 

1L, first-line; ADCC, antibody-dependent cell-mediated cytotoxicity; CDC, complement-dependent cytotoxicity; CRC, colorectal cancer; CT, chemotherapy; EGFR, epidermal growth factor receptor; EMA, European Medicines Agency; FDA, Food and Drug Administration; HPV, human papillomavirus; ICD, immunogenic cell death; IgG, immunoglobulin G; LA, locally advanced; mCRC, metastatic colorectal cancer; MoA, mechanism of action; mt, mutant; NK, natural killer; OS, overall survival; R/M, recurrent and/or metastatic; RT, radiotherapy; SCCHN, squamous cell carcinoma of the head and/or neck; wt, wild-type.

 

  1. Bray F, et al. CA Cancer J Clin 2024;74:229–263;
  2. GLOBOCAN. 2022. Available at: https://gco.iarc.fr/today/en/dataviz/mapsheatmap?mode=population&cancers=41 (last accessed August 2025);
  3. Cancer Tomorrow 2025. Available at: https://gco.iarc.fr/tomorrow/en/dataviz/tables?types=0&cancers=41&populations=903_904_905_908_909_935_900&years=2050 (last accessed August 2025);
  4. Keum N, Giovannucci E. Nat Rev Gastroenterol Hepatol 2019;16:713–732;
  5. Szturz P, et al. Cancer Treat Rev 2025;135:102910;
  6. Gormley M, et al. Br Dent J 2022;233:780–786;
  7. Taberna M, et al. Ann Oncol 2017;28:2386–2398;
  8. Barsouk A, et al. Med Sci (Basel) 2023;11:42;
  9. Chaturvedi AK, et al. J Clin Oncol 2013;31:4550–4559;
  10. Shaikh MH, et al. Cancer Epidemiol 2015;39:923–938;
  11. Ang KK, et al. Cancer Res 2002;62:7350–7356;
  12. Scaltriti M, Baselga J. Clin Cancer Res 2006;12:5268–5272;
  13. Herbst RS, Shin DM. Cancer 2002;94:1593–1611;
  14. Huang C-W, et al. BMC Cancer 2013;13:599;
  15. Zhao B, et al. Oncotarget 2017;8:3980–4000;
  16. Koncina E, et al. Cancers (Basel) 2020;12:319;
  17. Ross JS, et al. Am J Clin Pathol 2003;119:472–485;
  18. Martinelli E, et al. Clin Exp Immunol 2009;158:1–9;
  19. Ferris RL, et al. Cancer Treat Rev 2018;63:48–60;
  20. Goldstein NI, et al. Clin Cancer Res 1995;1:1311–1318;
  21. Sato JD, et al. Mol Biol Med 1983;1:511–529;
  22. Troiani T, et al. ESMO Open 2016;1:e000088;
  23. Erbitux® SmPC, December 2024;
  24. Bonner JA, et al. J Clin Oncol 2004;22(suppl 14):5507;
  25. EMA. 2004. Available at: https://www.ema.europa.eu/en/documents/scientific-discussion/erbitux-epar-scientific-discussion_en.pdf (last accessed August 2025);
  26. European Commission. 2004. European Commission Decision on Erbitux® - Marketing authorization. EMEA/H/C/558. Available at: https://ec.europa.eu/health/documents/community-register/html/h281.htm (last accessed August 2025);
  27. Food and Drug Administration. Information on Cetuximab (marketed as Erbitux®). Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/information-cetuximab-marketed-Erbitux® (last accessed August 2025);
  28. European Commission. 2006. European Commission Decision on Erbitux® – Amendment to marketing authorization. EMEA/H/C/558/II/5. Available at : https://ec.europa.eu/health/documents/
    communityregister/ (last accessed August 2025);
  29. Scientific discussion (module 8b of the epar). Available at: https://www.ema.europa.eu/en/documents/scientific-discussion-variation/erbitux-h-c-558-ii-0005-epar-scientific-discussion_en.pdf
    (last accessed August 2025);
  30. Vermorken JB, et al. N Engl J Med 2008;359:1116–1127;
  31. European Commission. 2008. European Commission Decision on Erbitux® – Amendment to marketing authorization. EMEA/H/C/558/II/26, 28. Available at: https://ec.europa.eu/health/documents/
    community-register/html/h281.htm (last accessed August 2025);
  32. EMA. 2013. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/Erbitux® (last accessed August 2025);
  33. Arnold D, et al. Ann Oncol 2017;28:1713–1729;
  34. Kopetz S, et al. N Engl J Med 2019;381:1632–1643;
  35. Van Cutsem E, et al. J Clin Oncol 2023;41:2628–2637;
  36. Tabernero J, et al. J Clin Oncol 2021;39:273–284;
  37. Yaeger R, et al. N Engl J Med 2023;388:44–54;
  38. Guigay J, et al. Lancet Oncol 2021;22:463–475;
  39. Zaryouh H, et al. Front Oncol 2021;11:697967;
  40. Vectibix® SmPC, July 2022;
  41. Clinicaltrials.gov. Available at: https://clinicaltrials.gov/search?intr=Erbitux (last accessed August 2025);
  42. Kopetz S, et al. ASCO GI 2025 (Abstract No. 16 – oral presentation);
  43. Kopetz S, et al. Nat Med 2025;31:901–908;
  44. Pfizer BRAFTOVI press release. Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizers-braftovir-combination-regimen-significantly (last accessed August 2025).

GL-ERB-00817 | January 2026

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