Erbitux gets nod from CHMP for new setting

German drug and chemicals firm Merck KGaA has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) for its application to broaden the use of the targeted cancer therapy Erbitux (cetuximab) to include the first-line treatment of metastatic colorectal cancer in patients with KRAS wild-type tumors.

The CHMP recommends the use of Erbitux in the treatment of patients with epidermal growth factor receptor-expressing, KRAS wild-type metastatic colorectal cancer, in combination with chemotherapy and as a single agent in people who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

The submission was supported in part by data analysis from the major randomized, controlled CRYSTAL and OPUS trials that demonstrated the efficacy of the agent in combination with standard chemotherapy, the firm noted, adding that the initial analyses of these trials in the overall population showed that the addition of Erbitux to standard chemotherapy regimens led to an increase in efficacy compared to chemotherapy alone.