EMEA refuses approval for Merck KGaA cancer treatment

Published: 20-Nov-2009

CHMP has again refused application for Erbitux (cetuximab)


The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has again refused Merck KGaA's application for approval of the use of Erbitux (cetuximab) in combination with platinum-based chemotherapy for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, advanced or metastatic non-small cell lung cancer (NSCLC).

The rejection came in spite of promising results in a randomised Phase III FLEXa study.

Merck KGaA says it is disappointed that NSCLC patients in Europe will not get to benefit from Erbitux.

The company submitted its original application to EMEA to license Erbitux for first-line treatment of NSCLC in September 2008. In July 2009 the CHMP said that "modest" benefits for the proposed wider use of the drug "did not outweigh its risks" and refused authorisation.

Merck KGaA says it remains committed to the clinical development programme for Erbitux, which includes clinical trials investigating the potential of the therapy in the treatment of various cancer types.

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