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FOLFIRINOX chemotherapy
FOLFIRINOX chemotherapy is a Platinum-based chemotherapy Small molecule drug developed by OncoSil Medical Limited. It is currently in Phase 2 development for Metastatic pancreatic cancer, Locally advanced pancreatic cancer. Also known as: Folinic Acid, 5-FU, Oxaliplatin, Irinotecan.
FOLFIRINOX is a chemotherapy regimen that combines four different drugs to target rapidly dividing cancer cells.
FOLFIRINOX is a chemotherapy regimen used to treat pancreatic cancer. It consists of a combination of four drugs, but the specific mechanism of action is not provided in the given facts, only that it acts as a granulocyte colony-stimulating factor receptor agonist.
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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 chemotherapy |
|---|---|
| Also known as | Folinic Acid, 5-FU, Oxaliplatin, Irinotecan |
| Sponsor | OncoSil Medical Limited |
| Drug class | Platinum-based chemotherapy |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
FOLFIRINOX is a combination chemotherapy regimen that includes oxaliplatin, leucovorin, 5-fluorouracil, and irinotecan. This combination works by inhibiting DNA replication and function in rapidly dividing cancer cells, ultimately leading to cell death.
Approved indications
- Metastatic pancreatic cancer
- Locally advanced pancreatic cancer
Common side effects
- Neutropenia
- Diarrhea
- Nausea
- Vomiting
- Fatigue
- Anemia
- Thrombocytopenia
- Anorexia
Key clinical trials
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma (EARLY_PHASE1)
- 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
- GATA6 Expression as a Predictor of Response to Peri-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma (NA)
- 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)
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 chemotherapy CI brief — competitive landscape report
- FOLFIRINOX chemotherapy updates RSS · CI watch RSS
- OncoSil Medical Limited portfolio CI
Frequently asked questions about FOLFIRINOX chemotherapy
What is FOLFIRINOX chemotherapy?
How does FOLFIRINOX chemotherapy work?
What is FOLFIRINOX chemotherapy used for?
Who makes FOLFIRINOX chemotherapy?
Is FOLFIRINOX chemotherapy also known as anything else?
What drug class is FOLFIRINOX chemotherapy in?
What development phase is FOLFIRINOX chemotherapy in?
What are the side effects of FOLFIRINOX chemotherapy?
Related
- Drug class: All Platinum-based chemotherapy drugs
- Manufacturer: OncoSil Medical Limited — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Metastatic pancreatic cancer
- Indication: Drugs for Locally advanced pancreatic cancer
- Also known as: Folinic Acid, 5-FU, Oxaliplatin, Irinotecan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing