April 6, 2021 - A new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (ERBITUX, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN).
April 6, 2021
On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (ERBITUX, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN).
This approval provides for a biweekly dosage regimen option in addition to the previously approved weekly dosage regimen for the approved indications when cetuximab is used as a single agent or in combination with chemotherapy.
The approval was based on population pharmacokinetic (PK) modeling analyses that compared the predicted exposures of cetuximab 500 mg Q2W to observed cetuximab exposures in patients who received cetuximab 250 mg weekly. The application 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, and OS analyses using real-world data in patients with mCRC who received either the weekly cetuximab or Q2W regimens. In these exploratory analyses, the observed efficacy results were consistent across dosage regimens and supported the results of the population PK modeling analyses.
The most common adverse reactions (incidence ≥25%) to cetuximab are cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhea, and infection.
For additional safety and efficacy information, and recommended dosage regimens, view full prescribing information for Erbitux.
The FDA approved this application approximately 5 months ahead of the FDA goal date.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.