FDA approves Erbitux (BMS/Merck-Serono) for metastatic Head and Neck Cancer

The FDA has approved Erbitux (cetuximab), from BMS/Merck-Serono, in combination with platinum-based chemotherapy with 5-fluorouracil, for the first-line treatment of recurrent locoregional or metastatic Head and Neck cancer. The drug is already FDA approved for some colon cancers and non-metastatic Head and Neck Cancer. The latest approval is based on data from the Phase III EXTREME trial which showed that Erbitux plus 5-fluorouracilin treatment of recurrent locoregional or metastatic Head and Neck Cancer resulted in superior efficacy for overall survival, progression-free survival, and objective response rates compared to chemotherapy with 5-fluorouracil alone. Erbitux plus chemotherapy significantly extended patients� median overall survival by 36%, and increased median progression-free survival by 67%, compated to chemotherapy alone.