Friday, May 30, 2008

Merck Receives CHMP Positive Opinion for Marketing Authorization for Erbitux Including First-Line Colorectal Cancer in the European Union

May 30, 2008 - Merck KGaA announced today that it received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), for its application to broaden the use of the targeted cancer therapy Erbitux® (cetuximab) to an enlarged label, also including 1st-line treatment of metastatic colorectal cancer (mCRC) in patients with KRAS wild-type tumors. The CHMP recommends the use of Erbitux in the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer, in combination with chemotherapy and as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.

The details can be read here.

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