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

PR69592

DARMSTADT, Germany, August 8, 2017 /PRNewswire=KYODO JBN/ --

    Not intended for U.K./U.S. based media

    - Decision secures access to Erbitux(R) for new patients in England with

oral cavity tumors

    - All patients currently receiving Erbitux(R) 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(R) (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/professionals/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:

http://www.who.int/selection_medicines/committees/expert/20/applications/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(R) (cetuximab) SmPC, Last updated June 2014. Available at:

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_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(R) (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

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company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

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