As a result of the approval, Erbitux can now be used in Japan in combination with chemotherapy in the first-line-treatment for patients with epidermal growth factor receptor (EGFR)-expressing, curatively unresectable (inoperable), advanced or recurrent colorectal cancer (mCRC) carrying the KRAS wildtype gene. The development is due to a change in the Japanese product information for Erbitux.
Merck KGaA said that the approval of the extended usage for Erbitux was granted following submission of data from the Phase III Crystal trial to Japan’s Pharmaceutical and Medical Devices Agency (PMDA).
The data demonstrated an overall survival advantage for patients who were treated with Erbitux in combination with Folfiri compared to those who received chemotherapy alone. In addition, the updated analysis showed that the combination of Erbitux and Folfiri reduced the risk of disease progression by 30% and increased the tumor response rate compared to chemotherapy alone.
Wayne Paterson, managing director of Merck Serono, said: “The striking improvement in response rates seen in patients treated with Erbitux added to chemotherapy is of vital importance in Japan. High response rates mean significant tumor shrinkage, and studies show that this leads to increased opportunities for complete removal of the tumor and a higher potential for the disease to be cured. This is of particular value in a country where cure rather than palliation is a primary treatment objective.”