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CDDP, 5 Fu
CDDP, 5 Fu is a Combination chemotherapy Small molecule drug developed by Gustave Roussy, Cancer Campus, Grand Paris. It is currently in Phase 2 development.
Combines cisplatin's DNA crosslinking with 5-FU's inhibition of thymidylate synthase to disrupt DNA synthesis and repair in cancer cells.
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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 | CDDP, 5 Fu |
|---|---|
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Drug class | Combination chemotherapy |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
Cisplatin forms platinum-DNA adducts that cause DNA crosslinks, triggering apoptosis. 5-Fluorouracil inhibits thymidylate synthase and incorporates into RNA/DNA, disrupting nucleotide synthesis. The combination provides synergistic cytotoxic effects through complementary mechanisms of DNA damage.
Approved indications
Common side effects
Key clinical trials
- Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (PHASE3)
- Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies (PHASE1)
- Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial (PHASE2)
- Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer (PHASE3)
- Study of Volrustomig as Monotherapy or in Combination With Anti- Cancer Agents in Participants With Advanced/Metastatic Solid Tumors (PHASE2)
- A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers (PHASE3)
- Durvalumab in Combination With Docetaxel, Cisplatin and 5-FU for Locally Advanced Head and Neck Squamous Cell Carcinoma (PHASE1)
- A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (PHASE3)
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:
- CDDP, 5 Fu CI brief — competitive landscape report
- CDDP, 5 Fu updates RSS · CI watch RSS
- Gustave Roussy, Cancer Campus, Grand Paris portfolio CI
Frequently asked questions about CDDP, 5 Fu
What is CDDP, 5 Fu?
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What drug class is CDDP, 5 Fu in?
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Related
- Drug class: All Combination chemotherapy drugs
- Manufacturer: Gustave Roussy, Cancer Campus, Grand Paris — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing