ImClone's Erbitux filed for refractory colorectal cancer in USA

ImClone Systems new antibody-based anticancer drug Erbitux (cetuximab;IMC-225) has been filed for approval in the USA in a rolling Biologics License Application. The drug, which targets the epidermal growth factor receptor expressed on a number of solid tumors, is being submitted in the first instance as a treatment for patients with colorectal cancer that is refractory to treatment with Pharmacia's topoisomerase inhibitor Camptosar (irinotecan).

ImClone has licensed co-promotion and co-development rights to Erbitux to Bristol-Myers Squibb in the USA, Canada and Japan, and to Merck KGaA in Europe (Marketletters passim).

In studies presented earlier this year, the combination of cetuximab and irinotecan achieved a 22.6% partial response rate, while an additional 7.5% of patients exhibited a stabilization in their disease in patients with refractory colorectal cancer (Marketletter May 21).