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FOLFIRINOX treatment
FOLFIRINOX treatment is a chemotherapy regimen Small molecule drug developed by Centre Georges Francois Leclerc. It is currently in Phase 2 development for Metastatic pancreatic cancer.
FOLFIRINOX is a chemotherapy regimen that combines four different drugs to target rapidly dividing cancer cells.
FOLFIRINOX is a chemotherapy regimen that combines four different drugs to target rapidly dividing cancer cells. Used for Metastatic pancreatic cancer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | FOLFIRINOX treatment |
|---|---|
| Sponsor | Centre Georges Francois Leclerc |
| Drug class | chemotherapy regimen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
FOLFIRINOX is a combination of the drugs 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin. This regimen works by inhibiting DNA synthesis and function, ultimately leading to cell death in rapidly dividing cancer cells.
Approved indications
- Metastatic pancreatic cancer
Common side effects
- Nausea
- Diarrhea
- Fatigue
- Neutropenia
- 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)
- MRI-Guided Adaptive Radiation Therapy for Organ Preservation in Rectal Cancer (PHASE1)
- FOLFIRINOX Induction Chemotherapy for Synchronous Liver Metastases
- Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) (PHASE1)
- Study-group on Palliative ERCP And RFA-ablation in Metastatic and Inoperable Pancreatic Tumors (NA)
- 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)
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:
- FOLFIRINOX treatment CI brief — competitive landscape report
- FOLFIRINOX treatment updates RSS · CI watch RSS
- Centre Georges Francois Leclerc portfolio CI
Frequently asked questions about FOLFIRINOX treatment
What is FOLFIRINOX treatment?
How does FOLFIRINOX treatment work?
What is FOLFIRINOX treatment used for?
Who makes FOLFIRINOX treatment?
What drug class is FOLFIRINOX treatment in?
What development phase is FOLFIRINOX treatment in?
What are the side effects of FOLFIRINOX treatment?
Related
- Drug class: All chemotherapy regimen drugs
- Manufacturer: Centre Georges Francois Leclerc — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic pancreatic cancer
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing