Eli Lilly And Co and Bristol-Myers Squibb Co Announce FDA Approval Of ERBITUX (cetuximab) as First-Line Treatment in KRAS Mutation-Negative (Wild-Type) Epidermal Growth Factor Receptor

Eli Lilly And Co and Bristol-Myers Squibb Co announced that ERBITUX (cetuximab) in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) has been granted full approval by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with KRAS mutation-negative (commonly known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) as determined by FDA-approved tests for this use. ERBITUX is not indicated for the treatment of KRAS mutation-positive colorectal cancer. Concurrently, the FDA also approved the first KRAS companion diagnostic test, the therascreen KRAS diagnostic kit developed by QIAGEN. 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 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 this trial and other clinical trial data, establish the efficacy of ERBITUX at the recommended dose in combination with FOLFIRI for first-line KRAS mutation-negative (wild-type) EGFR-expressing mCRC.