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Irinotecan + 5 FU + folinic acid
Irinotecan + 5 FU + folinic acid is a Combination chemotherapy (topoisomerase I inhibitor + antimetabolite) Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Metastatic colorectal cancer, Advanced gastric cancer, Pancreatic cancer.
This combination chemotherapy regimen kills cancer cells by inhibiting topoisomerase I (irinotecan) and blocking thymidylate synthase (5-FU with folinic acid potentiation).
This combination chemotherapy regimen kills cancer cells by inhibiting topoisomerase I (irinotecan) and blocking thymidylate synthase (5-FU with folinic acid potentiation). Used for Metastatic colorectal cancer, Advanced gastric cancer, Pancreatic cancer.
At a glance
| Generic name | Irinotecan + 5 FU + folinic acid |
|---|---|
| Sponsor | Pfizer |
| Drug class | Combination chemotherapy (topoisomerase I inhibitor + antimetabolite) |
| Target | Topoisomerase I; Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Irinotecan is a topoisomerase I inhibitor that prevents DNA religation, causing double-strand breaks during replication. 5-fluorouracil (5-FU) is a pyrimidine antimetabolite that inhibits thymidylate synthase, disrupting DNA synthesis. Folinic acid (leucovorin) enhances 5-FU efficacy by stabilizing its binding to thymidylate synthase. Together, these agents provide synergistic cytotoxic effects against rapidly dividing cancer cells.
Approved indications
- Metastatic colorectal cancer
- Advanced gastric cancer
- Pancreatic cancer
Common side effects
- Neutropenia
- Diarrhea
- Nausea/vomiting
- Anemia
- Mucositis
- Fatigue
- Alopecia
Key clinical trials
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Oxaliplatin Combined With Irinotecan Liposome Injection II Through Hepatic Artery Infusion (HAIC) Followed by 5-FU/LV (HAIC) or Tegorgor Oral Combination Therapy for Hepatic Metastasis of Pancreatic Cancer (PHASE2)
- A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer (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)
- Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread (PHASE2)
- 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)
- Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer (PHASE2, 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:
- Irinotecan + 5 FU + folinic acid CI brief — competitive landscape report
- Irinotecan + 5 FU + folinic acid updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Irinotecan + 5 FU + folinic acid
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Related
- Drug class: All Combination chemotherapy (topoisomerase I inhibitor + antimetabolite) drugs
- Target: All drugs targeting Topoisomerase I; Thymidylate synthase
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Advanced gastric cancer
- Indication: Drugs for Pancreatic cancer
- Compare: Irinotecan + 5 FU + folinic acid vs similar drugs
- Pricing: Irinotecan + 5 FU + folinic acid cost, discount & access