US FDA approves Erbitux as first-line treatment in KRAS wild-type EGFR

US drug majors Eli Lilly (NYSE: LLY) and Bristol-Myers Squibb (NYSE: BMY) on Friday received full approval from the Food and Drug Administration for their Erbitux (cetuximab) for a new indication, making it the first biologic treatment regimen cleared in nearly a decade for newly-diagnosed metastatic colorectal cancer (mCRC).

Erbitux, which is marketed by Germany’s Merck KGaA outside the USA, is now approved in combination with the chemotherapy regimen FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for the first-line treatment of patients with KRAS mutation-negative (commonly known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing (mCRC as determined by FDA-approved tests for this use. Erbitux is not indicated for the treatment of KRAS mutation-positive colorectal cancer.