Last reviewed 2026-05-27 · How we verify

FOLFIRI + cetuximab

FOLFIRI + cetuximab is a Chemotherapy combination + monoclonal antibody Small molecule drug developed by Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD). It is currently FDA-approved for Metastatic colorectal cancer, KRAS wild-type, Locally advanced colorectal cancer.

FOLFIRI chemotherapy combined with cetuximab targets rapidly dividing cancer cells and blocks epidermal growth factor receptor (EGFR) signaling to inhibit tumor growth.

FOLFIRI is a chemotherapy regimen used to treat various conditions, including metastatic colorectal cancer. Cetuximab, an epidermal growth factor receptor inhibitor, is often combined with FOLFIRI as a treatment for advanced colorectal cancer.

At a glance

Mechanism of action

FOLFIRI is a combination chemotherapy regimen (fluorouracil, leucovorin, and irinotecan) that damages DNA in dividing cells. Cetuximab is a monoclonal antibody that binds to EGFR on cancer cell surfaces, blocking growth signals and enhancing the cytotoxic effects of chemotherapy. This combination is particularly effective in colorectal cancers that express EGFR and are wild-type for KRAS.

Approved indications

• Metastatic colorectal cancer, KRAS wild-type
• Locally advanced colorectal cancer

Common side effects

• Neutropenia
• Diarrhea
• Nausea/vomiting
• Acneiform rash
• Anemia
• Fatigue
• Mucositis

Key clinical trials

• Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial (PHASE3)
• A Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer (PHASE3)
• A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation (PHASE1)
• EGF-Depleting Therapy CIMAvax-EGF in Combination With Standard Therapy for RAS- and BRAF Wild-Type Metastatic Colorectal Cancer (EARLY_PHASE1)
• Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Chinese Participants With Stage IV Colorectal Cancer (MK-3475-C66) (PHASE3)
• A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) (PHASE1)
• ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer (EARLY_PHASE1)
• TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• FOLFIRI + cetuximab CI brief — competitive landscape report
• FOLFIRI + cetuximab updates RSS · CI watch RSS
• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) portfolio CI

Frequently asked questions about FOLFIRI + cetuximab

Related

• Drug class: All Chemotherapy combination + monoclonal antibody drugs
• Target: All drugs targeting EGFR (epidermal growth factor receptor); DNA (via FOLFIRI)
• Manufacturer: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Metastatic colorectal cancer, KRAS wild-type
• Indication: Drugs for Locally advanced colorectal cancer

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing