Erbitux gains expanded approval in Europe

Cetuximab (Erbitux) has received broader approval in the European Union as a first-line treatment for metastatic colorectal cancer. Erbitux can now be used in European patients with EGFR-expressing, KRAS wild-type metastatic colorectal cancer in combination with chemotherapy and also as a single agent in patients who have failed oxaliplatin (Eloxatin)-based and irinotecan (Camptosar)-based therapy, according to manufacturer Merck KGaA of Darmstadt, Germany.

European Commission approval was based on data from two randomized, controlled trials. In the phase III CRYSTAL study, patients with KRAS wild-type tumors had a 59% response rate with cetuximab/chemotherapy vs 43% for chemotherapy alone. In the phase II OPUS trial, response rates were 61% vs 37%, respectively.