Eli Lilly and Co. (LLY) and Bristol-Myers Squibb Co.(BMY) 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 or 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.
The company said Erbitux is not indicated for the treatment of KRAS mutation-positive colorectal cancer.
The company said the FDA also approved the first KRAS companion diagnostic test, the therascreenKRAS diagnostic kit developed by QIAGEN.
The company said that 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.
The company said Erbitux provides approximately 22 percent 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.
The company added that 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. This is based on the positive CRYSTAL study with progression-free survival (PFS) as the primary endpoint in the all randomized patient population treated with EU-approved cetuximab plus FOLFIRI (the CRYSTAL regimen) versus FOLFIRI alone.
Erbitux is co-marketed by Bristol-Myers Squibb and Eli Lilly.
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