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Neoadjuvant FOLFOX
Neoadjuvant FOLFOX is a Combination chemotherapy regimen Small molecule drug developed by Kyungpook National University Hospital. It is currently in Phase 3 development for Neoadjuvant treatment of locally advanced colorectal cancer, Gastric and gastroesophageal junction cancers (neoadjuvant setting).
FOLFOX is a combination chemotherapy regimen that damages cancer cell DNA through multiple mechanisms to inhibit tumor growth and is used in the neoadjuvant setting to shrink tumors before surgery.
Neoadjuvant FOLFOX is a chemotherapy regimen used to treat various types of cancer, including gastric cancer, stomach cancer, colonic neoplasms, colon cancer, and neoplasms. The regimen involves the use of oxaliplatin, a small molecule DNA inhibitor, in combination with other drugs, such as paclitaxel and carboplatin, to target and inhibit cancer cells.
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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 | Neoadjuvant FOLFOX |
|---|---|
| Sponsor | Kyungpook National University Hospital |
| Drug class | Combination chemotherapy regimen |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FOLFOX combines 5-fluorouracil (5-FU), leucovorin (folinic acid), and oxaliplatin. 5-FU inhibits thymidylate synthase and is incorporated into DNA/RNA to disrupt synthesis. Oxaliplatin is a platinum agent that forms DNA cross-links, preventing replication. Leucovorin enhances 5-FU efficacy. In neoadjuvant therapy, the regimen is administered preoperatively to reduce tumor burden and improve surgical outcomes.
Approved indications
- Neoadjuvant treatment of locally advanced colorectal cancer
- Gastric and gastroesophageal junction cancers (neoadjuvant setting)
Common side effects
- Neutropenia
- Nausea and vomiting
- Diarrhea
- Peripheral neuropathy
- Anemia
- Mucositis
- Fatigue
Key clinical trials
- Perioperative Systemic Therapy for Isolated Resectable Colorectal Peritoneal Metastases (PHASE2, PHASE3)
- Neoadjuvant FOLFOXIRI and Chemoradiotherapy Versus Neoadjuvant CAPOX/FOLFOX and Chemoradiotherapy Followed by Surgery or a Watch-and-Wait Approach in High Risk Locally Advanced Rectal Cancer (PHASE3)
- Response Adapted Neoadjuvant Therapy in Gastroesophageal Cancers (RANT-GC Trial) (PHASE1)
- A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer (PHASE2)
- Neoadjuvant mFOLFOXIRI Plus Bevacizumab in Patients With High-Risk Locally Advanced Rectal Cancer (PHASE3)
- A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma (PHASE2)
- Yttrium-90 Radioembolization Neoadjuvant Therapy With Immune Marker Profiling and Dosimetry for Potentially Resectable Patients With Colorectal Liver Metastases
- Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer (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:
- Neoadjuvant FOLFOX CI brief — competitive landscape report
- Neoadjuvant FOLFOX updates RSS · CI watch RSS
- Kyungpook National University Hospital portfolio CI
Frequently asked questions about Neoadjuvant FOLFOX
What is Neoadjuvant FOLFOX?
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What is Neoadjuvant FOLFOX used for?
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Related
- Drug class: All Combination chemotherapy regimen drugs
- Manufacturer: Kyungpook National University Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Neoadjuvant treatment of locally advanced colorectal cancer
- Indication: Drugs for Gastric and gastroesophageal junction cancers (neoadjuvant setting)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing