FDA Approves New Dosing Regimen for Cetuximab

On 6 April 2021, the US Food and Drug Administration (FDA) 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 metastatic 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) modelling 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 modelling analyses.

The most common adverse reactions (incidence ≥25%) to cetuximab are cutaneous adverse reactions (including rash, pruritus, and nail changes), headache, diarrhoea, and infection.

For additional safety and efficacy information, and recommended dosage regimens, full prescribing information for Erbitux is available here.

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.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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