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mFOLFIRINOX regimen
mFOLFIRINOX regimen is a Combination chemotherapy regimen Small molecule drug developed by Revolution Medicines, Inc.. It is currently in Phase 3 development for Metastatic pancreatic cancer, Metastatic colorectal cancer, Gastric cancer. Also known as: modified FOLFIRINOX regimen, modified regimen of oxaliplatin, leucovorin, irinotecan, and fluorouracil (5-FU), Folic acid, 5- fluorouracil, irinotecan and oxaliplatin, Oxaliplatin.
mFOLFIRINOX is a chemotherapy regimen combining 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin to inhibit DNA synthesis and induce apoptosis in cancer cells.
mFOLFIRINOX is a chemotherapy regimen combining 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin to inhibit DNA synthesis and induce apoptosis in cancer cells. Used for Metastatic pancreatic cancer, Metastatic colorectal cancer, Gastric cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | mFOLFIRINOX regimen |
|---|---|
| Also known as | modified FOLFIRINOX regimen, modified regimen of oxaliplatin, leucovorin, irinotecan, and fluorouracil (5-FU), Folic acid, 5- fluorouracil, irinotecan and oxaliplatin, Oxaliplatin, Irinotecan |
| Sponsor | Revolution Medicines, Inc. |
| Drug class | Combination chemotherapy regimen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This is a combination chemotherapy regimen where each agent targets cancer cell proliferation through different mechanisms: 5-FU and leucovorin inhibit thymidylate synthase, irinotecan inhibits topoisomerase I, and oxaliplatin causes DNA cross-linking. The 'modified' (mFOLFIRINOX) version typically refers to adjusted dosing schedules designed to improve tolerability while maintaining efficacy compared to the standard regimen.
Approved indications
- Metastatic pancreatic cancer
- Metastatic colorectal cancer
- Gastric cancer
- Biliary tract cancer
Common side effects
- Neutropenia
- Diarrhea
- Nausea/vomiting
- Fatigue
- Peripheral neuropathy
- Anemia
- Thrombocytopenia
Key clinical trials
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP) (PHASE1, PHASE2)
- Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors (PHASE1, PHASE2)
- Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer (PHASE2)
- PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples (PHASE2)
- Acoustic Cluster Therapy (ACT) With Chemotherapy for the Treatment of Locally Advanced Pancreatic Cancer (PHASE2)
- Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma (PHASE2)
- A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer (PHASE1, PHASE2)
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:
- mFOLFIRINOX regimen CI brief — competitive landscape report
- mFOLFIRINOX regimen updates RSS · CI watch RSS
- Revolution Medicines, Inc. portfolio CI
Frequently asked questions about mFOLFIRINOX regimen
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Related
- Drug class: All Combination chemotherapy regimen drugs
- Manufacturer: Revolution Medicines, Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic pancreatic cancer
- Indication: Drugs for Metastatic colorectal cancer
- Indication: Drugs for Gastric cancer
- Also known as: modified FOLFIRINOX regimen, modified regimen of oxaliplatin, leucovorin, irinotecan, and fluorouracil (5-FU), Folic acid, 5- fluorouracil, irinotecan and oxaliplatin, Oxaliplatin, Irinotecan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing