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Published on 22 November 2013

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New biomarker data from OPUS receives CHMP positive opinion



Merck Serono, the biopharmaceutical division of Merck, has 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® (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 tumour 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, tumour samples of patients with KRAS wild-type tumour 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 tumours may benefit from treatment with Erbitux, while patients with RAS mutant tumours 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 personalised 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 randomised, controlled, Phase II trial, involving 337 mCRC patients, 179 with KRAS wild-type (exon 2) tumours, demonstrating the efficacy of Erbitux plus FOLFOX-4 (oxaliplatin-based therapy) versus FOLFOX-4 alone.(2) Results of a RAS tumour 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.

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