The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has adopted a negative opinion for 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).
Given the efficacy and significant overall survival benefit of Erbitux in NSCLC as demonstrated in the pivotal, randomized phase-III FLEXa study, Merck KGaA is disappointed that NSCLC patients in Europe will not get to benefit from Erbitux.
The company remains committed to the clinical development program for Erbitux, which includes clinical trials investigating the potential of the therapy in the treatment of various cancer types.
Erbitux is a first-in-class and highly active IgG1 monoclonal antibody targeting the epidermal growth factor receptor (EGFR).