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Merck Serono Announces CHMP Positive Opinion to Update Erbitux Metastatic Colorectal Cancer Labeling to Patients with RAS Wild-type Tumors

Darmstadt, Germany (ots/PRNewswire) -

- CHMP recommendation comes in response to new biomarker data obtained from
  the OPUS study

Merck Serono, the biopharmaceutical division of Merck, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on a variation to the Erbitux(R) (cetuximab) product information, updating the assessment of benefit-risk in patients with metastatic colorectal cancer (mCRC). The CHMP has recommended the approval of the indication for Erbitux in the treatment of patients with RAS wild-type mCRC, based on the totality of data emerging on the role of mCRC RAS tumor status in the benefit-risk profile of the drug. The recommendation primarily refers to new biomarker data from the OPUS study.[1]

In recent analyses of studies evaluating monoclonal anti-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 indicate that patients with RAS wild-type tumors may benefit from treatment with Erbitux, while patients with RAS mutant tumors may not.

"We are pleased with this important evolution of the label for Erbitux based upon new emerging data from our previous and ongoing studies of patients living with colorectal cancer," said Dr. Annalisa Jenkins, Head of Global Research and Development for Merck Serono. "As the molecular basis and understanding of disease evolves we are committed to embracing the principles of patient-centric drug development and personalized medicine."

Based on the CHMP's recommendation and pending agreement of the European Commission, Erbitux will be indicated for the treatment of patients with epidermal growth factor receptor-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 combination of Erbitux with oxaliplatin-containing chemotherapy would be contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.

About the OPUS Study

OPUS (OxaliPlatin and cetUximab in firSt-line treatment of mCRC) 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 have been submitted for presentation at Gastrointestinal Cancers Symposium (ASCO GI) 2014.

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]


1) Tejpar S et al. Submitted to 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:

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 93 countries. It has been approved for the treatment of colorectal cancer in 93 countries and for the treatment of squamous cell carcinoma of the head and neck (SCCHN) in 91 countries.

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. 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

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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 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.


Dr. Raphaela Farrenkopf, Phone +49-(0)6151-72-2274,

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