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

PR55387

DARMSTADT, Germany, Dec. 23/PRN=KYODO JBN/ --

    - 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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    Merck is a leading pharmaceutical, chemical and life science company with

total revenues of EUR 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

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approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and

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    Contact:

    Paul Olaniran

    Phone +49(0)6151-72-2274

    SOURCE: Merck Serono