DARMSTADT, Germany,
Aug. 8, 2017 /CNW/ -
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
- 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.
- 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.
- 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.
- Merck, Data on file, September
2016.
- 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.
- Specenier P, et al. Biologics. 2013;7:77-90.
- 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.
- Vermorken J, et al. Ann Oncol.
2010;21(Suppl.7):vii252-61.
- Vokes E, et al. J Natl Cancer Inst.
2015;107:djv344.
- Erbitux® (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.
- 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 €15.0 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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SOURCE Merck