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FDA Approves Combination of Erbitux (Cetuximab) and FOLFIRI Regimen as First-Line Treatment for Metastatic Colorectal Cancer

The new indication is based on data from the CRYSTAL (Cetuximab combined with iRinotecan in first-line therapY for metaSTatic colorectAL cancer) trial, a phase III open-label, randomized, multicenter study conducted outside the U.S. that used European Union (EU)-approved cetuximab as the clinical trial material. Erbitux provides approximately 22% higher exposure relative to the EU-approved cetuximab; these pharmacokinetic data, together with the results of the landmark CRYSTAL trial and other clinical trial data, established the efficacy of Erbitux at the recommended dose in combination with FOLFIRI for first-line KRAS mutation-negative (wild-type) EGFR-expressing mCRC.

Erbitux is now the first and only FDA-approved therapy for a specific subset of mCRC patients, targeting those with KRAS mutation-negative (wild-type) tumors.

Data from the CRYSTAL study, along with other cetuximab studies, demonstrate the importance of testing for KRAS status at diagnosis of mCRC to identify appropriate patients for Erinitux therapy. Both the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines, Category 2A) and the American Society of Clinical Oncology (ASCO) recommend KRAS gene testing in colorectal cancer patients at diagnosis of metastatic disease.

For more information, here's the news release from Eli Lilly.

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