Merck KGaA

NICE Recommends Erbitux® in Combination with Platinum-Based Chemotherapy for the Treatment of Recurrent and/or Metastatic Head and Neck Cancer in the Oral Cavity

Darmstadt, Germany (ots/PRNewswire) - Not intended for U.K./U.S. based media

- Decision secures access to Erbitux® for new patients in England 
  with oral cavity tumors 
- All patients currently receiving Erbitux® will  have continued 
  access    

Merck, a leading science and technology company, announced today that the National Institute for Health and Care Excellence (NICE) for England has issued a positive Final Appraisal Determination (FAD) recommending the routine National Health Service (NHS) use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy as a first-line therapy for the treatment of patients with recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) in the oral cavity.[1] NICE's decision confirms the positive benefit Erbitux can have on the survival of patients in this setting. Erbitux is already established and reimbursed as an effective therapy for different stages of SCCHN across many countries worldwide.

"This announcement secures continued access to Erbitux for patients in England who have R/M SCCHN with oral cavity tumors - a positive step forward as the only other available treatment option is platinum-based chemotherapy. Our ultimate goal is to secure access to Erbitux for all patients living with R/M SCCHN," said Maya Martinez-Davis, Global Head of Oncology Franchise for Merck's biopharma business. "Today's recommendation marks another important achievement in our commitment to ensuring that patients worldwide have access to optimal treatments."

For patients with R/M SCCHN, Erbitux has been available in England through the Cancer Drugs Fund (CDF) since 2010. This was in line with the current European Society for Medical Oncology and the US National Comprehensive Cancer Network clinical practice guidelines. Both guidelines recommend Erbitux in combination with platinum-based chemotherapy, followed by Erbitux maintenance monotherapy to disease progression, as the first line standard of care for patients with R/M SCCHN, regardless of tumor location.[2],[3]

In 2016, a new approach to the appraisal and funding of cancer drugs in England came into place and all drugs previously funded by the CDF had to be reassessed by NICE. The reassessment reviews if the treatments bring sufficient clinical benefit to patients to be a cost-effective use of NHS resources.

Erbitux has obtained marketing authorization in over 90 countries worldwide. To date, more than 259,000 patients with SCCHN have been treated with Erbitux.[4]

For further information and press materials please visit http://www.merckgroup.com

References

 1. National Institute For Health and Care Excellence. Cetuximab for 
    treating recurrent or metastatic squamous cell cancer of the head
    and neck. Final Appraisal Determination. Issued August 2017.
 2. Grégoire V, et al. Ann Oncol 2010;21 (Suppl 5): v184-v186. 
    Available from: http://annonc.oxfordjournals.org/content/21/suppl
    _5/v184.full.pdf+html. Accessed June 2017.
 3. National Comprehensive Cancer Network (NCCN). Clinical Practice 
    Guidelines in Oncology (NCCN Guidelines). Head and Neck Cancers. 
    Version 2.2016. Available from: https://www.nccn.org/professional
    s/physician_gls/f_guidelines.asp#head-and-neck. Accessed June 
    2017.
 4. Merck, Data on file, September 2016.
 5. National Cancer Institute. Head and neck cancers fact sheet. 
    Available at: 
 https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet
    Accessed June 2017.
 6. Specenier P, et al. Biologics. 2013;7:77-90.
 7. Union for International Cancer Control. 2014 Review of Cancer 
    Medicines on the WHO List of Essential Medicines: locally 
    advanced squamous carcinoma of the head and neck. Available at: h
    ttp://www.who.int/selection_medicines/committees/expert/20/applic
    ations/HeadNeck.pdf Accessed June 2017.
 8. Vermorken J, et al. Ann Oncol. 2010;21(Suppl.7):vii252-61.
 9. Vokes E, et al. J Natl Cancer Inst. 2015;107:djv344.
10. Erbitux® (cetuximab) SmPC, Last updated June 2014. Available at: 
 http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produ
    ct_Information/human/000558/WC500029119.pdf Accessed June 2017.
11. Baselga J. Oncologist. 2002;7(Suppl 4):2-8. 

About the NICE process

By publishing a Final Appraisal Determination (FAD), the National Institute for Health and Care Excellence (NICE) has made final recommendations on how Erbitux with platinum-based chemotherapy therapy should be used in the NHS. If there are no successful appeals, the final recommendations will be issued as NICE guidance.

About head and neck cancer

Head and neck (H&N) cancer is a disease that occurs in the cells that line tissues or organs in the head and neck region. This can include the oral cavity, throat (pharynx), voice box (larynx), nasal cavity and salivary glands.[5] More than 90% of H&N cancers begin in the flat squamous cells that line surfaces such as the mouth, nose and throat.[6] This is called squamous cell carcinoma of the head and neck (SCCHN). SCCHN is the sixth most common cancer worldwide.[7] Prognosis is dependent on the stage of the disease and worsens as the disease advances. 60% of people with H&N cancer are diagnosed when the disease is in an advanced stage.[8] Recurrent cancer means that the disease has come back after a period of time when it could not be detected. When cancer has spread to another part of the body it is called metastatic disease. When cancer spreads from where it started to nearby tissue of lymph nodes it is called locally advanced cancer. Once H&N cancer reoccurs or spreads outside of the neck, the prognosis is poor, with a median life expectancy of only 10 months.[9]

About Erbitux

Erbitux® (cetuximab) is an epidermal growth factor receptor (EGFR) monoclonal antibody (mAb) approved to treat two different types of cancer: RAS wild-type metastatic colorectal cancer (mCRC) and squamous cell cancer of the head and neck (SCCHN).[9] The active substance in Erbitux, cetuximab, is a monoclonal antibody. A monoclonal antibody is a type of protein that has been designed to recognize and attach to a specific structure (called an antigen) in the body. Erbitux has been designed to attach to the EGFR, which can be found on the surface of some tumor cells.[10] One of the mechanisms of action is considered to be antibody-dependent cell-mediated cytotoxicity (ADCC).[10] The EGF receptor is one of the most important pathways that regulate the growth, survival and increase of cells. Abnormal activity of the EGFR has been shown to play a key role in the development and growth of tumor cells.[11] The EGFR is involved in switching on genes called RAS that are involved in the growth of cells; Erbitux works by binding to the EGFR. As a result of this binding, the cancer cell can no longer receive the messages it needs for growth, progression and metastasis.[10]

The most characteristic adverse events are skin reactions, which occur in more than 80% of patients, hypomagnesemia, which occurs in more than 10% of patients and infusion-related reactions, which occur with mild to moderate symptoms in more than 10% of patients and with severe symptoms in more than 1% of patients.[10]

Erbitux has already obtained market authorization in over 90 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer (mCRC) 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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About Merck

Merck 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 2016, Merck generated sales of EUR15.0 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, 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.

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