DARMSTADT, Germany,
December 23, 2013 /PRNewswire/ --
- The European Commission's approval is based on the CHMP
positive opinion
- Label update comes in response to new biomarker data
obtained from the OPUS study
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.[1]
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 not.
"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.[2]
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.[3] 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.[3] Almost 60% of the cases occur in developed
regions, and incidence and mortality rates are substantially higher
in men than in women.[3] In Europe alone, an estimated 436,000 people
develop CRC every year, with approximately 212,000 people dying
from the disease annually.[4]
References
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.
About Erbitux
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
growth.
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 severe.
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 immunology.
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.
Contact:
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Phone +49(0)6151-72-2274
