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mFOLFOX6 6 month
mFOLFOX6 6 month is a Small molecule drug developed by NRG Oncology. It is currently in Phase 2 development.
The mFOLFOX6 regimen is used in combination with other treatments in clinical trials for various types of cancer, including gastric, gastroesophageal, and colorectal cancer. The mFOLFOX6 regimen is not directly mentioned in the provided facts, but it is a known chemotherapy regimen that typically includes oxaliplatin, 5-fluorouracil, and leucovorin.
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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).
| 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 | mFOLFOX6 6 month |
|---|---|
| Sponsor | NRG Oncology |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Peripheral sensory neuropathy
- Neutrophil count decreased
- Diarrhea
- Fatigue
- White blood cell decreased
- Thromboembolic event
- Dehydration
- Depression
- Hypertension
- RCCEP
- Vomiting
Key clinical trials
- Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (PHASE2, PHASE3)
- FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer (PHASE4)
- Modulated Electro-Hyperthermia in Combination With Multimodal Therapy for Locally Advanced Rectal Cancer (PHASE3)
- Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer (PHASE2)
- COLONYVAQ™, a Quantum-Classical Guided Personalized Neoantigen Vaccine for MSS Stage III Colorectal Cancer (EARLY_PHASE1)
- Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418) (PHASE3)
- Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI (PHASE2)
- A Study of DKN-01 in Combination With Tislelizumab ± Chemotherapy in Patients With Gastric or Gastroesophageal 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:
- mFOLFOX6 6 month CI brief — competitive landscape report
- mFOLFOX6 6 month updates RSS · CI watch RSS
- NRG Oncology portfolio CI
Frequently asked questions about mFOLFOX6 6 month
What is mFOLFOX6 6 month?
Who makes mFOLFOX6 6 month?
What development phase is mFOLFOX6 6 month in?
What are the side effects of mFOLFOX6 6 month?
Related
- Manufacturer: NRG Oncology — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing