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

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.