FDA Approves New Cetuximab Dose in KRAS Wild-Type, EGFR-Expressing CRC, Head and Neck Cancer

April 7, 2021

Article

The FDA has approved a new biweekly dosing regimen of 500 mg/m2 as a 120-minute intravenous infusion for cetuximab (Erbitux) for patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck.

FDA

The FDA has approved a new biweekly dosing regimen of 500 mg/m² as a 120-minute intravenous infusion for cetuximab (Erbitux) for patients with KRAS wild-type, EGFR-expressing colorectal cancer (CRC) or squamous cell carcinoma of the head and neck (SCCHN).

With this regulatory decision, a biweekly dosing option is now available in addition to the weekly dosage regimen that had previously been approved for all approved indications when the agent is used either as a monotherapy or it is combined with chemotherapy.

The approval was based on findings from population pharmacokinetic modeling analyses that compared the predicted exposures of cetuximab delivered at a biweekly dose of 500 mg vs observed exposures in patients who received the agent at a weekly dose of 250 mg.

The application was also supported by data from pooled analyses of overall response rates, progression-free survival, and overall survival (OS) from published literature of cetuximab in patients with CRC and SCCHN. OS analyses that comprised real-world findings in patients with metastatic CRC who received either the weekly or biweekly dosing regimens was also used to support the decision.

In these exploratory analyses, the efficacy data proved to be consistent across dosage regimens examined and served to further support the data reported in the population pharmacokinetic modeling analyses.

The most common frequently reported toxicities with cetuximab include cutaneous adverse reactions such as rash, pruritus, and nail changes. Other adverse effects experienced with the agent include headache, diarrhea, and infection.