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www.fdanews.com/articles/101874-amgen-cancer-drug-receives-ec-nod

Amgen Cancer Drug Receives EC Nod

December 6, 2007
The European Commission (EC) has granted a conditional marketing authorization for Amgen’s Vectibix as monotherapy for the treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal cancer (mCRC) with nonmutated KRAS genes after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.

Vectibix (panitumumab) also is approved in the U.S. for this indication.

Phase III trials are exploring the potential of administering Vectibix in combination with chemotherapy in the first- and second-line of mCRC, as well as in head and neck cancer, Amgen said.