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Erbitux® (Cetuximab): Importance of establishing wild type RAS status (exons 2,3,4 of KRAS and NRAS) before treatment in metastatic colorectal cancer (mCRC)

Date: 17 April 2014

Description: A Direct Healthcare Professional Communication (DHPC) has been approved by NPCB to inform healthcare professionals regarding the contraindication of Erbitux®involving additional mutations of RAS beyond KRAS Codons 12/13. Evidence of wild-type RAS (exons 2, 3 and 4 of KRAS and NRAS) status is required before initiating treatment with Erbitux®. RAS mutational status should be determined by an experienced laboratory using a validated test method. The contraindication for Erbitux® in combination with oxaliplatin-containing chemotherapy (e.g.FOLFOX) now includes all patients with mutant RAS or unknown RAS status. Merck(M) Sdn. Bhd. is updating the package insert to incorporate the new efficacy and safety updates.Please refer to the letter for further information.

(FOLFOX: oxaliplatin plus continuosinfusional 5-fluorouracil/folinic acid; KRAS: Kirsten Rat Sarcoma; NRAS: Neuroblastoma Rat Sarcoma)

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