European Commission Approves Update of Erbitux Metastatic Colorectal Cancer Labeling to Patients With RAS Wild-Type Tumors

Darmstadt, Germany (ots/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(R) (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 Belen
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(R) 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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Contact:

Paul Olaniran
Phone +49(0)6151-72-2274

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