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Folinic Acid + 5 FU
Folinic acid enhances the cytotoxic activity of 5-fluorouracil (5-FU) by stabilizing the ternary complex between 5-FU metabolites and thymidylate synthase, thereby increasing DNA synthesis inhibition and cancer cell death.
Folinic acid enhances the cytotoxic activity of 5-fluorouracil (5-FU) by stabilizing the ternary complex between 5-FU metabolites and thymidylate synthase, thereby increasing DNA synthesis inhibition and cancer cell death. Used for Metastatic colorectal cancer, Adjuvant treatment of stage III colorectal cancer, Advanced gastric cancer.
At a glance
| Generic name | Folinic Acid + 5 FU |
|---|---|
| Sponsor | Pfizer |
| Drug class | Antimetabolite chemotherapy combination |
| Target | Thymidylate synthase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
5-FU is a pyrimidine antimetabolite that inhibits thymidylate synthase, blocking DNA synthesis. Folinic acid (leucovorin) provides reduced folate cofactors that stabilize the binding of fluorodeoxymonophosphate to thymidylate synthase, prolonging enzyme inhibition and enhancing 5-FU cytotoxicity. This combination is a standard chemotherapy regimen used in colorectal and other gastrointestinal cancers.
Approved indications
- Metastatic colorectal cancer
- Adjuvant treatment of stage III colorectal cancer
- Advanced gastric cancer
- Pancreatic cancer
Common side effects
- Neutropenia
- Diarrhea
- Mucositis
- Nausea/vomiting
- Anemia
- Hand-foot syndrome
- Fatigue
Key clinical trials
- A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer (PHASE2)
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
- Studying Chemotherapy With or Without Panitumumab for Unresectable, Locally Advanced, or Metastatic Pancreatic Cancer Without KRAS Mutations (PHASE3)
- Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study (PHASE3)
- Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) (PHASE2)
- Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer (PHASE1)
- Oxaliplatin, Leucovorin, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon 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:
- Folinic Acid + 5 FU CI brief — competitive landscape report
- Folinic Acid + 5 FU updates RSS · CI watch RSS
- Pfizer portfolio CI