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Published on 29 July 2008

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European approval for Erbitux

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Merck Serono has received European approval for broader usage of Erbitux in metastatic colorectal cancer (mCRC).

Merck KGaA now have permission to update its licence for the treatment of patients with epidermal growth factor receptor, KRAS wild-type mCRC.

The European Commission today announced their approval for Erbitux in combination with chemotherapy, and as a single agent in patients who have failed oxaliplatin, as well as for those who are intolerant to irinotecan.

“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,” commented Professor Eric Van Cutsem, Professor of Medicine and Digestive Oncology at the University Hospital Gasthuisberg.

He added: “We are excited by the data supporting this approval as it demonstrates the increased efficacy of Erbitux in patients who have KRAS wild-type tumours.”

The approval was granted following trials that demonstrated the efficacy of Erbitux with chemotherapy in the first line treatment of patients with mCRC compared to chemotherapy as a sole treatment.

Further analyses found that patients with KRAS wild-type tumours have a significantly higher response rate.

“Erbitux is a key new treatment option for two-thirds of all metastatic colorectal cancer patients because the KRAS status of their tumours is predictive for the efficacy of Erbitux,” said Wolfgang Wein, Executive Vice President, Oncology. “These findings are an important step forward in the development of tailored therapies.”

So far, more than 120,000 patients have been treated with commercially available Erbitux worldwide.

Merck



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