FDA Approves Novel Dosing Regimen for Cetuximab in CRC, Head and Neck Cancer

On April 6, 2021, the FDA approved a novel dosing regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN).

With this newly approved dosage of cetuximab, providers will have a biweekly dosing option for patients in addition to the previously approved weekly dosing option. Cetuximab can be dosed alone or in combination with chemotherapy.

To add, this approval was based on population pharmacokinetic (PK) modeling analyses, which compared the expected exposures of cetuximab 500 mg Q2W to observed cetuximab exposures within patients who received cetuximab 250 mg on a weekly basis.

Furthermore, the application was also supported by pooled analyses of overall response rates, progression-free survival, and overall survival (OS) in patients with CRC and SCCHN, and OS analyses using real-world data in patients with mCRC who received either the weekly cetuximab or Q2W regimens.The perceived efficacy results were congruent across dosage regimens and supported the results of the population PK modeling analyses.

The most common (≥25%) adverse reactions associated with cetuximab included cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection. Alexis Hyams

US Food and Drug Administration. FDA approves new dosing regimen for cetuximab. April 8, 2021.

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