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FOLFOX plus targeted therapy
FOLFOX plus targeted therapy is a Combination chemotherapy plus targeted therapy Small molecule drug developed by Shanghai Zhongshan Hospital. It is currently in Phase 3 development for Colorectal cancer (likely metastatic or advanced stage, specific targeted agent and patient population not specified).
FOLFOX chemotherapy combined with targeted therapy agents works by inhibiting DNA synthesis and cell division while blocking specific oncogenic signaling pathways.
FOLFOX chemotherapy combined with targeted therapy agents works by inhibiting DNA synthesis and cell division while blocking specific oncogenic signaling pathways. Used for Colorectal cancer (likely metastatic or advanced stage, specific targeted agent and patient population not specified).
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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 | FOLFOX plus targeted therapy |
|---|---|
| Sponsor | Shanghai Zhongshan Hospital |
| Drug class | Combination chemotherapy plus targeted therapy |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
FOLFOX is a combination chemotherapy regimen (5-fluorouracil, leucovorin, and oxaliplatin) that damages cancer cell DNA and prevents replication. The addition of targeted therapy—likely directed at EGFR, VEGF, or other pathway-specific targets—further inhibits tumor growth by blocking specific molecular drivers of cancer progression. This dual approach aims to improve efficacy over chemotherapy alone.
Approved indications
- Colorectal cancer (likely metastatic or advanced stage, specific targeted agent and patient population not specified)
Common side effects
- Neutropenia
- Peripheral neuropathy
- Diarrhea
- Nausea/vomiting
- Anemia
- Mucositis
Key clinical trials
- Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With Gastric Cancer Spread to the Abdominal Cavity (PHASE2, PHASE3)
- Conversion Therapy With FOLFOX-HAIC Plus Lenvatinib And Tislelizumab For Hepatocellular Carcinoma With Vp3 Portal Vein Tumor Thrombus (PHASE2)
- A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC) (PHASE1)
- A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation. (PHASE1)
- Epacadostat (INCB024360) Added to Preoperative Chemoradiation in Patients With Locally Advanced Rectal Cancer (PHASE1, PHASE2)
- Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy (PHASE2)
- Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients (PHASE2)
- Oncolytic Virus (H101) + SBRT + Chemotherapy + Targeted Therapy + Immunotherapy for Unresectable CRLM (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:
- FOLFOX plus targeted therapy CI brief — competitive landscape report
- FOLFOX plus targeted therapy updates RSS · CI watch RSS
- Shanghai Zhongshan Hospital portfolio CI
Frequently asked questions about FOLFOX plus targeted therapy
What is FOLFOX plus targeted therapy?
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Who makes FOLFOX plus targeted therapy?
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Related
- Drug class: All Combination chemotherapy plus targeted therapy drugs
- Manufacturer: Shanghai Zhongshan Hospital — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Colorectal cancer (likely metastatic or advanced stage, specific targeted agent and patient population not specified)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing