Bristol-Myers Squibb announced that Erbitux (cetuximab), in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), has been approved as first-line treatment in KRAS mutation-negative, epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC).  In addition, the FDA has also approved the first KRAS companion diagnostic test, the therascreen KRAS diagnostic kit developed by Qiagen.

This approval is based on data from the CRYSTAL (Cetuximab combined with iRinotecan in first-line therapY for metaSTatic colorectAL cancer) trial, a Phase 3 open-label, randomized, multicenter study. The patients were randomized to be treated with European Union (EU)-approved cetuximab plus FOLFIRI or FOLFIRI alone. Study data showed that Erbitux provided approximately 22% higher exposure relative to the EU-approved cetuximab.

Erbitux is already approved for certain types of colon cancer, metastatic head and neck cancer in combination with other chemotherapy, and non-metastatic head and neck cancer in combination with radiation therapy (first-line) or as a single agent (following standard treatment).

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