In July 2012, cetuximab was approved for use in combination with FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) for first-line treatment of patients with KRAS mutation-negative (wild-type), EGFR-expressing metastatic colorectal cancer (mCRC) as determined by Food and Drug Administration-approved tests. A companion diagnostic, Therascreen KRAS RGQ PCR Kit for determining KRAS mutation status was approved concurrently with the cetuximab approval. The test is a real-time polymerase chain reaction assay that detects 7 mutations of the KRAS gene; tumors with none of these mutations are considered wild-type KRAS tumors.
*For PDFs of the full article and accompanying Commentary, click on the links to the left of this introduction.