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Cetuximab labeling revised for KRAS mutations
The FDA has approved revisions to the U.S. prescribing information for cetuximab concerning the treatment of patients with epidermal growth factor receptor expressing metastatic colorectal cancer.
The new labeling includes a statement that retrospective studies of metastatic or advanced colorectal cancers trials have shown no treatment benefit for the use of cetuximab (Erbitux, ImClone) in patients whose tumors had KRAS mutations in codon 12 or 13 and that the use of cetuximab is not recommended for the treatment of cancer in these patients.
In recent months the American Society of Clinical Oncology and the National Comprehensive Cancer Network issued guidelines recommending that all patients with metastatic colorectal cancer be tested for KRAS mutations prior to treatment with any anti-EGFR monoclonal antibody.
For the treatment of metastatic colorectal cancer, cetuximab is approved by the FDA as: a single agent for the treatment of EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens; a single agent for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant to irinotecan-based regimens; and in combination with irinotecan for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are refractory to irinotecan-based chemotherapy.