The FDA has approved Erbitux™ (cetuximab) in combination with FOLFIRI for first-line treatment of patients with metastatic colorectal cancer whose tumors have a wild-type (WT) KRAS gene. Erbitux was first approved in 2004 for patients whose cancer was not responding to available treatments.
FDA’s action was prompted by results from a look back at patient outcomes and KRAS status from three trials:
- CRYSTAL: phase 3, 1217 patients newly diagnosed with metastatic CRC, comparing FOLFIRI vs FOLFIRI + Erbitux
- OPUS: phase 2, 337 patients newly diagnosed with metastatic CRC, comparing FOLFOX vs FOLFOX + Erbitux
- CA225025: phase 3, 572 patients with metastatic CRC that stopped responding to available treatments, comparing Best Supportive Care (BSC) to BSC + Erbitux