European Commission approves update of Erbitux

03-Jan-2014 - Germany

Merck Serono announced that the European Commission has approved the Type II variation to amend the Erbitux® (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.

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