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Erbitux gets extended European approval
01 Dec 2008
Regulatory Affairs
Merck KGaA and its Merck Serono division have announced that the cancer drug Erbitux has gained extended approval from the European commission.
The new regulatory decision relates to the use of Erbitux as a first-in-line treatment for patients with recurrent or metastatic squamous cell carinoma of the head and neck.
Erbitux had already been approved for use in combination with radiotherapy in the treatment of locally-advanced disease.
Dr Wolfgang Wein, executive vice-president of oncology at Merck Serono, said the decision was "fantastic news".
"This latest approval recognises the impressive potential of Erbitux to extend patients' lives and further confirms the high activity of Erbitux against difficult-to-treat cancers," he added.
Merck KGaA had recently reported positive data from a clinical trial of the drug in its potential treatment of lung cancer.
The company said patients given Erbitux in addition to a standard first-line platinum-based chemotherapy lived significantly longer than those patients who were solely given chemotherapy.
