Merck KGaA submits Erbitux license application

Merck KGaA has announced the submission of a new licence application for Erbitux (cetuximab) as a first-line treatment for non-small cell lung cancer (NSCLC) in Europe.

The firm has submitted its application to the European Medicines Agency for the epidermal growth factor receptor in patients with advanced or metastatic forms of the disease.

Its application is supported by data from the phase III Flex study presented earlier this year at the plenary session of the annual meeting of the American Society of Clinical Oncology.

The Flex study showed the administration of Erbitux in combination with a platinum-based chemotherapy showed a significant increase in overall survival in patients.

Dr Wolfgang Wein, executive vice-president of oncology at Merck Serono, said: “Erbitux represents the first significant and clinically relevant advance in ten years in the treatment of such a broad patient population in NSCLC.”

He added that, if it receives regulatory approval in this indication, Erbitux would provide patients with a new treatment option for an aggressive and difficult-to-treat cancer and expand the number of patients who are able to benefit from the compound.

Earlier this month, Bristol-Myers Squibb and ImClone Systems announced positive results for Erbitux with platinum-based chemotherapy in patients with recurrent or metastatic head and neck cancer.