Cetuximab

Pharmacogenomic Information in the Context of the FDA-Approved Drug Label*

The cetuximab drug label contains information about EGFR-expressing cancers, and was updated on July 17, 2009 to include information about treatment of patients with KRAS mutations.

Excerpt from the cetuximab drug label:

"Erbitux is an epidermal growth factor receptor (EGFR) antagonist indicated for treatment of:
. . .
Colorectal Cancer

• As a single agent, EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens or in patients who are intolerant to irinotecan-based regimens. (1.2, 14.2)
• In combination with irinotecan, EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy. Approval is based on objective response rate; no data are available demonstrating an improvement in increased survival. (1.2, 14.2)
• Retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for Erbitux in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Erbitux is not recommended for the treatment of colorectal cancer with these mutations. (1.2, 12.1, 14.2)"

For the complete drug label text with sections containing pharmacogenetic information highlighted, see the Cetuximab drug label PDF, updated 7/17/2009.