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Home Industry News Merk KGaA reports European approval for Erbitux

Merk KGaA reports European approval for Erbitux

31st July 2008

Merck KGaA has announced it has received approval for the broader use of Erbitux (cetuximab) in metastatic colorectal cancer patients (mCRC) from the European Commission, including first-line treatment.

The company has been granted approval to update its licence for the compound to cover the first-line treatment of patients with epidermal growth factor receptor-expressing KRAS wild-type mCRC in combination with chemotherapy.

It is also now indicated as a single agent in patients who are intolerant to irinotecan or who have failed oxaliplatin and irinotecan-based chemotherapy regimens.

The compound has been approved for use as a treatment for locally-advanced squamous cell carcinoma of the head and neck since April 2006 and mCRC since June 2004.

Professor Eric Van Cutsem, professor of medicine and digestive oncology at the University Hospital Gasthuisberg in Leuven, Belgium, said: “This broad approval of Erbitux in metastatic colorectal cancer is welcomed by the oncology community as it provides us with another treatment option for our patients in the first-line setting.”

He added this approval shows the increased efficacy of Erbitux in patients with KRAS wild-type tumours.

Earlier this month, Merck KGaA announced the initiation of a phase III study of Erbitux in combination with Xeloda (capecitabine) and cisplatin in advanced oesophago-gastric cancer.

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