Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that EGFR positive, Wild type KRAS status confers therapeutic sensitivity to Cetuximab in patients with Colorectal Adenocarcinoma.
The U.S. Food and Drug Administration granted approval to cetuximab for the treatment of patients with K-Ras wild-type, EGFR-expressing metastatic colorectal cancer, as determined by an FDA-approved test, who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.
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 as a single-agent in patients who have failed oxaliplatin- and irinotecan-based chemotherapy or who are intolerant to irinotecan.