The Food and Drug Administration (FDA) has approved a new biweekly dosage regimen for Erbitux (cetuximab) for patients with K-Ras wild-type, epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). The new dosing schedule is in addition to the approved weekly dosage regimen.
For patients with K-Ras wild-type, EGFR-expressing mCRC or SCCHN, Erbitux may now be administered as 500mg/m2 as a 120-minute intravenous (IV) infusion every 2 weeks for initial and subsequent doses.
The approval was based on pharmacokinetic modeling analyses that compared the predicted exposures of Erbitux 500mg every 2 weeks to observed Erbitux exposures in patients who received Erbitux 250mg weekly. The new biweekly dosing regimen was also supported by pooled analyses of overall response rates, progression-free survival, and overall survival (OS) from published literature in patients with CRC and SCCHN, as well as OS analyses from real-world data in patients with mCRC treated with either the weekly or biweekly regimen.
Erbitux, an EGFR antagonist, is supplied as 50mL and 100mL single-dose vials containing 100mg and 200mg of cetuximab, respectively.
FDA approves new dosing regimen for cetuximab. [press release]. Silver Spring, MD: US Food and Drug Administration; April 6, 2021.