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Erbitux receives EU approval for first-line head and neck cancer

This article was originally published in Scrip

Executive Summary

The European Commissionhas approved ImClone Systems/Bristol-Myers Squibb/Merck KGaA'sEGFR-targeted anticancer Erbitux (cetuximab) for first-line use in recurrent and/or metastatic head and neck cancer in combination with chemotherapy. Erbitux was previously approved for use in combination with radiotherapy for locally advanced disease. The approval is supported by the results of the EXTREME study, which investigated the efficacy of Erbitux in combination with platinum-based chemotherapy in first-line recurrent and/or metastatic SCCHN. Overall survival increased from 7.4 to 10.1 months. In September, ImClone filed an application with the US FDA to broaden the use of Erbitux for the same use (Scrip Online, September 9th, 2008). Erbitux's biggest indication is for the treatment of advanced colorectal cancer. Other EGFR-targeted drugs that have been tested in head and neck cancer, such as AstraZeneca's Iressa (gefitinib) and Genentech/Roche's Tarceva (erlotinib), have so far shown only modest antitumour activity. GlaxoSmithKline's Tykerb (lapatinib), a dual EGFR and HER2 targeted drug, is in Phase III trials in the adjuvant disease setting.



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