CHMP recommends update to Erbitux indication for mCRC-Merck Serono

The CHMP has issued a positive opinion on a variation to the product information for Erbitux (cetuximab), from Merck Serono, 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.

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.