New Biweekly Dosage of Cetuximab Receives FDA Approval for CRC, HNSCC Subtypes

The FDA recently granted approval to a new dosing regimen for cetuximab to treat patients with KRAS wild-type, EGFR-expressing colorectal cancer or head and neck squamous cell carcinoma.

The FDA recently approved a new dosing regimen for cetuximab (Erbitux) to treat patients with KRAS wild-type, EGFR-expressing colorectal cancer (mCRC) or head and neck squamous cell carcinoma (HNSCC), according to the agency.1

The new dosage regimen for cetuximab is 500 mg/m2 as a 120-minute intravenous infusion every 2 weeks, which was approved nearly 5 months ahead of schedule.

The approval now adds to the existing dosage regimen options for patients with these disease types, adding a biweekly option to the already existing weekly dosage regimen of cetuximab’s approved indications as a single agent or in combination with chemotherapy.

This new dosage regimen’s approval came after the predicted exposures of cetuximab at the 500 mg regimen were compared by population pharmacokinetic modeling analyses to the observed cetuximab exposures in patients who received the cetuximab 250 mg weekly regimen.

More, existing literature for pooled analyses of overall response rates, progression-free survival, and overall survival (OS) supported this approval for patients with mCRC and HNSCC. Real-world data from OS analyses for patients with mCRC who received either the weekly or biweekly cetuximab regimen also supported the application’s approval.

Overall, the efficacy data that was observed in these analyses was consistent across both the weekly and biweekly cetuximab dosage regimens, while also supporting the data from the population pharmacokinetic modeling analyses.

Common adverse events (defined as occurring in 25% or more of patients) for patients treated with cetuximab include cutaneous adverse reactions, headache, diarrhea, and infection.

According to the American Cancer Society (ACS), colorectal cancer is the third most common cancer in the United States for both men and women, with an estimated almost 150,000 new cases of the disease for 2021. More, the disease is the third most common cause of cancer deaths for men and women, with almost 53,000 people estimated to die from colorectal cancer in 2021.2

As for HNSCC, head and neck cancers account for about 4% of all cancer cases in the United States. It’s estimated that almost 67,000 people will develop head and neck cancer in 2021, with almost 15,000 people dying from this disease.3


1. FDA approves new dosing regimen for cetuximab. News release. FDA. Published April 7, 2021. Accessed April 7, 2021.

2. Key Statistics for Colorectal Cancer. American Cancer Society. Published January 12, 2021. Accessed April 7, 2021.

3. Head and Neck Cancer: Statistics. Cancer.Net Editorial Board. Published January 2021. Accessed April 7, 2021.