The European Commission's approval is based on the CHMP positive opinion
Label update comes in response to new biomarker data obtained from the
DARMSTADT, Germany, Dec. 23, 2013 /CNW/ - Merck Serono, the
biopharmaceutical division of Merck, today announced that the European
Commission has approved the Type II variation to amend the Erbitux® (cetuximab) product information, updating the indication for Erbitux to
the treatment of patients with RAS wild-type metastatic colorectal
cancer (mCRC). The approval of the European Commission follows the
positive opinion from the Committee for Medicinal Products for Human
Use (CHMP) (issued in November 2013) and is based on the totality of
data emerging on the role of mCRC RAS tumor status in the benefit-risk
profile of the drug. The approval primarily refers to new biomarker
data from the OPUS (OxaliPlatin and cetUximab in firSt-line treatment of mCRC) study.
In recent analyses of studies evaluating monoclonal anti-epidermal
growth factor receptor (EGFR) antibodies, such as Erbitux, tumor
samples of patients with KRAS wild-type tumor status (exon 2) were
assessed for additional RAS mutations (defined as mutations in exons 3
or 4 of KRAS and/or exons 2, 3 or 4 of NRAS). The results from these
studies suggest that patients with RAS wild-type tumors may benefit
from treatment with Erbitux, while patients with RAS mutant tumors may
"We fully endorse the update to the indication of Erbitux in metastatic
colorectal cancer, as it will provide further guidance to physicians
who manage patients with colorectal cancer," said Belén Garijo,
President and CEO of Merck Serono. "We will now be working with the
regulatory agencies to effectively communicate the implications of this
label change to healthcare professionals and patients."
In the updated product information, Erbitux will now be indicated for
the treatment of patients with EGFR-expressing, RAS wild-type mCRC in
combination with irinotecan-based chemotherapy, in 1st line in
combination with FOLFOX, or as a single agent in patients who have
failed oxaliplatin- and irinotecan-based therapy and who are intolerant
to irinotecan. In this label change, the existing contraindication for
the combination of Erbitux with oxaliplatin-containing chemotherapy is
now extended to include patients with mutant RAS mCRC or for whom RAS
mCRC status is unknown.
The full Erbitux patient information will be publicly available in the
revised SmPC. Once updated, this will be available online at http://www.ema.europa.eu/ema
About the OPUS Study
OPUS is a randomized, controlled, Phase II trial, involving 337 mCRC
patients, 179 with KRAS wild-type (exon 2) tumors, demonstrating the
efficacy of Erbitux plus FOLFOX-4 (oxaliplatin-based therapy) versus
FOLFOX-4 alone. Results of a RAS tumor status analysis will be presented at
Gastrointestinal Cancers Symposium (ASCO GI) in January 2014, in San
Francisco, California, U.S..
About Colorectal Cancer
Colorectal cancer (CRC) is the fourth most common cancer worldwide, with
an estimated incidence of more than 1.2 million cases globally. An estimated 608,000 deaths from CRC occur worldwide each year,
accounting for 8% of all cancer deaths and making it the fourth most
common cause of death from cancer. Almost 60% of the cases occur in developed regions, and incidence and
mortality rates are substantially higher in men than in women. In Europe alone, an estimated 436,000 people develop CRC every year,
with approximately 212,000 people dying from the disease annually.
1. Tejpar S, et al. Accepted at 2014 Gastrointestinal Cancers Symposium,
January 16-18, 2014.
2. Bokemeyer C, et al. Ann Oncol 2011;22(7):1535-46.
3. Ferlay J, et al. Int J Cancer 2010;127(12):2893-917.
4. Ferlay J, et al. Eu J Cancer 2010;46(4):765-81.
For more information on Erbitux in colorectal and head & neck cancer,
please visit http://www.globalcancernews.com.
Erbitux® is a first-in-class and 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
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
Erbitux has already obtained market authorization in over 90 countries
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 U.S. and Canada
from ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company,
in 1998. In Japan, ImClone, Bristol-Myers Squibb Company and Merck
jointly develop and commercialize Erbitux. Merck has an ongoing
commitment to the advancement of oncology treatment and is currently
investigating novel therapies in highly targeted areas.
About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With
headquarters in Darmstadt, Germany, Merck Serono offers leading brands
in 150 countries to help patients with cancer, multiple sclerosis,
infertility, endocrine and metabolic disorders as well as
cardiovascular diseases. In the United States and Canada, EMD Serono
operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription
medicines of both chemical and biological origin in specialist
indications. We have an enduring commitment to deliver novel therapies
in our core focus areas of neurology, oncology, immuno-oncology and
For more information, please visit http://www.merckserono.com.
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Merck is a leading pharmaceutical, chemical and life science company
with total revenues of € 11.2 billion in 2012, a history that began in
1668, and a future shaped by approx. 38,000 employees in 66 countries.
Its success is characterized by innovations from entrepreneurial
employees. Merck's operating activities come under the umbrella of
Merck KGaA, in which the Merck family holds an approximately 70%
interest and free shareholders own the remaining approximately 30%. In
1917 the U.S. subsidiary Merck & Co. was expropriated and has been an
independent company ever since.
SOURCE: Merck Sereno
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