FDA Approves New Dosing Regimen for Erbitux to Treat Specific Subtype of Colorectal Cancer, Head and Neck Cancer


A once-every-two-week regimen of Erbitux has been approved by the FDA, which provides patients with KRAS wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck another treatment option.

A new dosing regimen for Erbitux (cetuximab) has been approved by the Food and Drug Administration (FDA) for the treatment of patients with KRAS wild-type, EGFR-expressing colorectal cancer or those with squamous cell carcinoma of the head and neck.

The agency approved a 500 milligram/meter2 dose of Erbitux to be administered as a 120-minute intravenous infusion every two weeks for these two patient populations, according to a news alert from the FDA. This biweekly regimen provides another dosing option, with the previously approved option being a weekly dosage regimen when used alone or in combination with chemotherapy.

The approval of this new dosing regimen was based on analyses comparing predicted exposures to 500 milligrams of Erbitux once every two weeks with observed exposures to Erbitux in patients who received 250 milligrams of the drug weekly. The FDA also reviewed analyses from published literature and real-world data in these patient populations.

The most common side effects related to Erbitux include headache, infection, diarrhea and skin-related conditions including itching, rash and nail changes.

KRAS wild-type is a protein produced by KRAS genes which instructs cells to grow, divide or mature and provides the ability for normal cells to become cancerous. EGFR is another protein that’s found on certain cells and is involved in cell signaling pathways that control cell survival and division. Mutations in the EGFR gene can cause these proteins to be produced in higher amounts for some types of cancer.

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