Merck KGaA calls for CHMP Erbitux decision re-examination

31 July 2009

German drug major Merck KGaA says that it has requested re-examination of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), for the use of Erbitux (cetuximab) in combination with platinum-based chemotherapy for the first-line treatment of patients with non-small cell lung cancer (NSCLC). Taking the opinion seriously Merck will work closely with the CHMP to unravel the value of Erbitux for patients benefit most.

The decision to request re-examination follows consultation with key stakeholders in the NSCLC treatment community, coupled with Merck's confidence in the clinical data supporting Erbitux in this potential indication.
Based on the Phase III study FLEX Erbitux has been acknowledged in the oncology academic community:

The data from the FLEX study were presented in the plenary session during the 2008 annual meeting of the American Society of Clinical Oncology (ASCO) ─ the worldwide leading cancer congress.

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