The US Food and Drug Administration (FDA) has approved Eli Lilly and Bristol-Myers Squibb’s Erbitux (cetuximab) in combination with Folfiri (irinotecan, 5-fluorouracil, leucovorin) as a first-line treatment for KRAS mutation-negative, epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC).

The approval was based on positive data from the multicentre, open-label, randomised Cetuximab Combined with Irinotecan in First-Line Therapy for Metastatic Colorectal Cancer (CRYSTAL) Phase 3 study.

In the study, patients were randomised to receive either EU-approved cetuximab with Folfiri or Folfiri alone as first-line treatment.

The study’s primary endpoint was progression-free survival (PFS) in all randomised patients, whilst the secondary endpoints were overall survival and response rate.

"PFS, median overall survival and objective response rates improved in patients in the cetuximab plus Folfiri arm."

The data demonstrated that PFS, median overall survival and objective response rates improved in patients in the cetuximab plus Folfiri arm, compared with the Folfiri alone arm.

CRYSTAL trial lead investigator and professor of medicine and digestive oncology at the University Hospital Gasthuisberg, Eric Van Cutsem, said: "Both response rates and overall survival in KRAS wild-type patients treated with the CRYSTAL regimen are important when considering the treatment options for patients with first-line mCRC."

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The University of Texas MD Anderson Cancer Center spokesperson, John Mendelsohn, said: "Research results have consistently demonstrated that KRAS is an important biomarker in mCRC, underscoring the need for all patients with this disease to undergo testing for KRAS status at initial diagnosis."

Eli Lilly and Company oncology product development and medical affairs vice president, Richard Gaynor, said: "The totality of the data from CRYSTAL, along with data from other ERBITUX trials, provides compelling and consistent evidence of the benefit of ERBITUX in the treatment of KRAS mutation-negative (wild-type) EGFR-expressing mCRC."