Merck receives European approval for Erbitux in head and neck cancer

By Lisa Kerner

Erie, Pa., April 3 - Merck KGaA said the European Commission has granted marketing authorization to extend the use of the targeted cancer therapy Erbitux (cetuximab), in combination with radiotherapy, for the treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

The marketing authorization is based on results of an international, randomized phase 3 study of 424 patients, according to a company news release.

Patients treated with Erbitux combined with radiotherapy had a median survival significantly improved by nearly 20 months, with the duration of locoregional control improved by 9.5 months compared to radiotherapy alone.

Erbitux will be available for the treatment of head and neck cancer in all 25 member states of the European Union as well as Iceland and Norway. It is licensed in 53 countries for metastatic colorectal cancer after failure of irinotecan-based chemotherapy, Merck said.

"Erbitux takes head and neck cancer treatment an enormous step forward, providing more patients with the potential for a long-term benefit or cure. We are conscious that these results open a new era in the management of locally advanced SCCHN [squamous cell carcinoma of the head and neck]," senior vice president global oncology commercialization Dr. Wolfgang Wein said in the release.

"The approval of Erbitux across the E.U. for a second indication is a continuation of our commitment to ongoing research in the oncology field, with the aim of improving the health and quality of life for cancer patients."

Merck, a pharmaceutical company based in Darmstadt, Germany, licensed the right to market Erbitux outside the United States and Canada from ImClone Systems Inc.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.