On April 6, 2021, the U.S. Food and Drug Administration (FDA) approved a new dosage regimen for cetuximab (Erbitux®) of 500 mg/m2 via IV infusion for 120 minutes every two weeks for patients with KRAS wild-type, epidermal growth factor receptor-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN).
FDA previously approved a weekly dosage regimen for the indications when cetuximab is used as a single agent or in combination with chemotherapy.
The most recent approval was based on population pharmacokinetic (PK) modeling analyses that compared the predicted exposures of cetuximab 500 mg every two weeks to observed exposures in patients who received 250 mg weekly. The approval was also supported by pooled analyses of overall response rates, progression-free survival, and overall survival (OS) from published studies of patients with mCRC and SCCHN and OS analyses using real-world data of patients with mCRC who received the regimens weekly or every two weeks. In those 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 (≥ 25%) were headache, diarrhea, infection, and cutaneous adverse reactions, including rash, pruritus, and nail changes.
For additional safety and efficacy information and recommended dosage regimens, view full prescribing information for cetuximab.
FDA approved the application approximately five months ahead of its goal date. A description of FDA expedited programs is in the Guidance for Industry—Expedited Programs for Serious Conditions—Drugs and Biologics.
Healthcare professionals should report all serious adverse events they suspect are associated with the use of any medicine or device to FDA’s MedWatch Reporting System or by calling 800-FDA-1088.
For assistance with single-patient oncology investigational new drug applications, contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.