Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that EGFR positive, Wild type KRAS status confers therapeutic sensitivity to Cetuximab, Irinotecan in patients with Colorectal Adenocarcinoma.

The U.S. Food and Drug Administration granted approval to cetuximab in combination with irinotecan for the treatment of patients with K-Ras wild-type, EGFR-expressing metastatic colorectal

This statement is based on a regulatory approval from the Food and Drug Administration:

ERBITUX is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer as determined by an FDA-approved test in combination with irinotecan in patients who are refractory to irinotecan-based chemotherapy.

Citation

ImClone LLC. Erbitux (cetuximab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125084s279lbl.pdf. Revised September 2021. Accessed October 30, 2024.