European Commission backs wider use of Merck's Erbitux

Merck Serono, the biopharmaceutical division of Germany’s Merck KGaA (MRK: DE), has gained European Commission approval for the Type II variation to amend the Erbitux (cetuximab) product information, updating the indication for the drug to the treatment of patients with RAS wild-type metastatic colorectal cancer (mCRC).

Shares of Merck, which markets the cancer drug Erbitux outside the USA, advanced 0.9% to 129.85 euros on the news. The drug, in its current indications, generated sales of around $1.2 billion for the German drugmaker last year.

The approval follows the positive opinion from the European Medicines Agency’s 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, the company noted.