Merck KGaA has submitted an application to the European Medicines Agency to broaden the use of the cancer therapy, Erbitux to include first-line therapy for the treatment of metastatic colorectal cancer.
The submission is supported in part by data from the CRYSTAL study presented at ASCO in June that demonstrates the efficacy of Erbitux (cetuximab) as a first-line treatment in mCRC patients which showed that, when added to current standard irinotecan based chemotherapy in first-line, the compound significantly increased progression-free survival, response and resection rates.
This means that as well as improving efficacy of first-line chemotherapy, Erbitux is the only targeted therapy to increase the chance of cure through resection and the submission also includes the broadened use of Erbitux in pre-treated mCRC patients based on two further Phase III studies.
Merck licenses the drug from ImClone Systems and has rights for key regions including Europe. Erbitux was first approved for treatment of mCRC after irinotecan failure in Switzerland in December 2003, in the USA in February and in Europe in June 2004. In Europe, more than 370,000 people develop colorectal cancer every year.