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Infusional 5-FU/LV with Irinotecan
Infusional 5-FU/LV with Irinotecan is a Chemotherapy combination (antimetabolite + topoisomerase I inhibitor) Small molecule drug developed by Pfizer. It is currently in Phase 3 development for Metastatic colorectal cancer (first-line), Advanced colorectal cancer.
This combination chemotherapy regimen inhibits DNA synthesis and topoisomerase I to kill rapidly dividing cancer cells.
This combination chemotherapy regimen inhibits DNA synthesis and topoisomerase I to kill rapidly dividing cancer cells. Used for Metastatic colorectal cancer (first-line), Advanced colorectal cancer.
At a glance
| Generic name | Infusional 5-FU/LV with Irinotecan |
|---|---|
| Sponsor | Pfizer |
| Drug class | Chemotherapy combination (antimetabolite + topoisomerase I inhibitor) |
| Target | Thymidylate synthase (5-FU); Topoisomerase I (Irinotecan) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
5-FU (fluorouracil) is a pyrimidine antimetabolite that inhibits thymidylate synthase and gets incorporated into DNA/RNA, disrupting nucleotide synthesis. Irinotecan is a topoisomerase I inhibitor that prevents DNA religation, causing double-strand breaks during replication. Leucovorin (LV) enhances 5-FU efficacy by stabilizing the 5-FU–thymidylate synthase complex. Together, these agents provide synergistic cytotoxic activity against colorectal cancer cells.
Approved indications
- Metastatic colorectal cancer (first-line)
- Advanced colorectal cancer
Common side effects
- Neutropenia
- Diarrhea
- Nausea/vomiting
- Anemia
- Mucositis
- Fatigue
- Cholinergic syndrome (acute)
Key clinical trials
- A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients (PHASE1)
- A Phase III Study of 2nd-line XELIRI ± Bevacizumab vs. FOLFIRI ± Bevacizumab in mCRC (PHASE3)
- A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC (PHASE3)
- First-line FOLFOXIRI In Combination With Bevacizumab For Metastatic Colorectal Cancer (PHASE2)
- Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine. (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:
- Infusional 5-FU/LV with Irinotecan CI brief — competitive landscape report
- Infusional 5-FU/LV with Irinotecan updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Infusional 5-FU/LV with Irinotecan
What is Infusional 5-FU/LV with Irinotecan?
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What drug class is Infusional 5-FU/LV with Irinotecan in?
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Related
- Drug class: All Chemotherapy combination (antimetabolite + topoisomerase I inhibitor) drugs
- Target: All drugs targeting Thymidylate synthase (5-FU); Topoisomerase I (Irinotecan)
- Manufacturer: Pfizer — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic colorectal cancer (first-line)
- Indication: Drugs for Advanced colorectal cancer