Merck’s Erbitux wins positive opinion from CHMP

The Committee for Medicinal Products for Human Use (CHMP) recommends the use of Erbitux in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer, in combination with chemotherapy and as a single agent in patients 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 Erbitux in combination with standard chemotherapy in the first-line treatment of patients with metastatic colorectal cancer. The initial analyses of Crystal and Opus trials in the overall population showed that the addition of Erbitux to standard chemotherapy regimens (Folfiri and Folfox) led to an increase in efficacy compared to chemotherapy alone.

The Opus trial demonstrated that this effect was even more pronounced in patients with KRAS wild-type tumors, which was reflected in increased response rates, increased progression free survival times and in a decreased risk of progression. As a result, the future product labeling for Erbitux is expected to take into consideration the KRAS mutational status of the patient’s tumor.

Wolfgang Wein, executive vice president of oncology for Merck Serono, said: “The positive opinion from the CHMP is an important step forward in the management of colorectal cancer and a step closer to tailored therapy for cancer patients.”