(ChemotherapyAdvisor) – The United States Food and Drug Administration (FDA) approved cetuximab for first-line treatment of patients with KRAS mutation-negative epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin), according to a July 6 joint press release from Eli Lilly and Company (Indianapolis, IN) and Bristol-Myers Squibb (New York, NY).

According to the press release, this is the first and only FDA-approved, biomarker-directed therapy for a specific subset of newly diagnosed EGFR-expressing metastatic colorectal cancer (mCRC) patients, targeting those with KRAS mutation-negative tumors. A companion diagnostic kit for the detection of the KRAS mutation has been concurrently approved by the FDA.

“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 3, open label, randomized, multicenter study conducted outside the United States,” the company wrote.

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The positive CRYSTAL study, with progression-free survival (PFS) as the primary end point, involved the randomization of the patient population treated with EU-approved cetuximab plus FOLFIRI (the CRYSTAL regimen) vs FOLFIRI alone.

ERBITUX®, which is the form of cetuximab approved in the United States, provides approximately 22% higher exposure relative to the EU-approved cetuximab. Taken together, pharmacokinetic data, the results of the CRYSTAL trial, and other clinical trial data, it was possible for the drug manufacturers to establish the efficacy of ERBITUX at the recommended dose in combination with FOLFIRI for first-line KRAS mutation-negative (wild-type) EGFR-expressing mCRC.