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FOLFIRI regimen
FOLFIRI is a chemotherapy regimen that combines three drugs to inhibit DNA synthesis and cell division, primarily targeting rapidly dividing cancer cells.
FOLFIRI is a chemotherapy regimen that combines three drugs to inhibit DNA synthesis and cell division, primarily targeting rapidly dividing cancer cells. Used for Metastatic colorectal cancer, Advanced colorectal cancer.
At a glance
| Generic name | FOLFIRI regimen |
|---|---|
| Also known as | FOLFIRI, Irinotecan Hydrochloride from Pfizer+Folinic acid+5-fluorouracil (5-FU) |
| Sponsor | National Cancer Institute (NCI) |
| Drug class | Chemotherapy regimen (combination of antimetabolite and topoisomerase I inhibitor) |
| Target | Thymidylate synthase (5-FU), Topoisomerase I (irinotecan) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FOLFIRI consists of 5-fluorouracil (5-FU), leucovorin (folinic acid), and irinotecan (CPT-11). 5-FU is a pyrimidine antimetabolite that inhibits thymidylate synthase and gets incorporated into DNA/RNA. Leucovorin enhances 5-FU's effect by stabilizing its binding to thymidylate synthase. Irinotecan is a topoisomerase I inhibitor that prevents DNA unwinding and repair, leading to DNA damage and cell death.
Approved indications
- Metastatic colorectal cancer
- Advanced colorectal cancer
Common side effects
- Neutropenia
- Diarrhea
- Nausea/vomiting
- Anemia
- Mucositis
- Fatigue
- Alopecia
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.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FOLFIRI regimen CI brief — competitive landscape report
- FOLFIRI regimen updates RSS · CI watch RSS
- National Cancer Institute (NCI) portfolio CI