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

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When Avastin is added to the combination of Xeloda and irinotecan as an initial treatment for advanced colorectal cancer, the treatment is equally effective as Avastin with FOLFIRI.

But side effects are more difficult.

After a randomized clinical trial comparing Avastin with XELIRI (Xeloda, irinotecan) to Avastin with FOLFIRI (5-FU, leucovorin, irinotecan), researchers concluded that excessive side effects made using the XELIRI combination unwise. Read the rest of this entry »