FDA Approves New Erbitux Dosing Regimen

FDA has approved a new dosage regimen — 120-minute intravenous infusion every two weeks — for Imclone’s Erbitux (cetuximab) for treating patients with K-Ras wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck. This dosage option is in addition to the previously approved weekly dosage regimen for approved indications when cetuximab is used as a single agent or in combination with chemotherapy, an agency release says. The submission was approved five months ahead of the FDA goal date.

Approval was based on population pharmacokinetic modeling analyses that compared the predicted exposures of cetuximab 500 mg every two weeks to observed cetuximab exposures in patients who received cetuximab 250 mg weekly, according to FDA. The submission was also supported by pooled analyses of overall response rates, progression-free survival, and overall survival from published literature, it says.