Last reviewed 2026-04-20 · How we verify

Folfiri (folfiri)

FOLFIRI is a chemotherapy regimen for metastatic colorectal cancer and adjuvant treatment of stage III colon cancer. It is made up of folinic acid, fluorouracil, and irinotecan. FOLFIRI works by decreasing the cytotoxicity of 5-fluorouracil and preventing DNA from uncoiling and duplicating. This combination therapy is effective in treating colorectal cancer. FOLFIRI is marketed by Pfizer Inc. and has a significant revenue potential. The drug has undergone numerous clinical trials and has been published in over 2,000 studies. FOLFIRI's mechanism of action and clinical efficacy make it a valuable treatment option for patients with colorectal cancer.

At a glance

Approved indications

• Metastatic colorectal cancer
• Adjuvant treatment of colon cancer
• First-line treatment of metastatic colorectal cancer
• Second-line treatment of metastatic colorectal cancer
• Treatment of unresectable or metastatic colorectal cancer
• Treatment of colorectal cancer that has spread to the liver
• Treatment of colorectal cancer that has spread to the peritoneum
• Treatment of colorectal cancer that has spread to the ovary
• Treatment of colorectal cancer that has spread to the pancreas
• Treatment of colorectal cancer that has spread to the lung
• Treatment of colorectal cancer that has spread to the brain
• Treatment of colorectal cancer that has spread to the bone
• Treatment of colorectal cancer that has spread to the adrenal gland
• Treatment of colorectal cancer that has spread to the kidney
• Treatment of colorectal cancer that has spread to the thyroid gland
• Treatment of colorectal cancer that has spread to the heart
• Treatment of colorectal cancer that has spread to the esophagus
• Treatment of colorectal cancer that has spread to the stomach
• Treatment of colorectal cancer that has spread to the small intestine
• Treatment of colorectal cancer that has spread to the liver and the colon

Common side effects

No common side effects on file.

Drug interactions

• Bevacizumab
• Cyclosporine
• Lapatinib
• Pazopanib
• Sorafenib
• Sunitinib
• Tamoxifen
• Trastuzumab
• Vandetanib
• Vorinostat

Key clinical trials

• Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE) (PHASE2)
• A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LRK-4189 Alone and in Combination in Patients With Solid Tumors (PHASE1, PHASE2)
• A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer (PHASE2, PHASE3)
• Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (PHASE3)
• Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
• 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)
• Using Healthy Gut Bacteria to Boost Immune Treatment for Advanced Bowel Cancer (EARLY_PHASE1)
• 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)

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 CI brief — competitive landscape report
• Folfiri updates RSS · CI watch RSS
• Pfizer portfolio CI