Merck Applies to Extend Use of Erbitux for Colorectal Cancer

Merck has submitted an application to the European medicines agency to broaden the use of its targeted cancer therapy, Erbitux, to include first-line therapy for the treatment of metastatic colorectal cancer.

The submission is supported in part by data from a study that demonstrated the efficacy of Erbitux as a first-line treatment in metastatic colorectal cancer (mCRC) patients.

The study showed that, when added to current standard Camptosar (irinotecan)-based chemotherapy in first-line, Erbitux significantly increased progression-free survival, response and resection rates. According to Merck, this means that as well as improving efficacy of first-line chemotherapy, Erbitux is the only targeted therapy to increase the chance of cure through resection.

The Phase III study of Erbitux plus Folfiri compared with Folfiri alone met the primary endpoint of significantly increasing median duration of progression-free survival in patients with previously untreated mCRC.

The side effects of Erbitux in combination with chemotherapy were manageable and consistent with the current safety information.

The application for first-line indication will be reviewed by the committee for medicinal products for human use (CHMP). If approved by the European Commission, Merck says patients within Europe may start benefiting from Erbitux as a first-line therapy from the second half of next year.

Erbitux was first approved for treatment of mCRC after irinotecan failure in Switzerland in December 2003. It was also approved for treatment of mCRC after irinotecan failure in the US by the FDA in February 2004 and was followed by EMEA approval in June 2004.