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Isolated pelvis perfusion
Isolated pelvis perfusion is a Small molecule drug developed by Gustave Roussy, Cancer Campus, Grand Paris. It is currently in Phase 3 development for Advanced pelvic malignancies (sarcoma, gynecologic cancers, colorectal cancer), Locally advanced or unresectable pelvic tumors.
Isolated pelvic perfusion delivers high-dose chemotherapy directly to pelvic tumors while minimizing systemic exposure through regional vascular isolation.
Isolated pelvic perfusion delivers high-dose chemotherapy directly to pelvic tumors while minimizing systemic exposure through regional vascular isolation. Used for Advanced pelvic malignancies (sarcoma, gynecologic cancers, colorectal cancer), Locally advanced or unresectable pelvic tumors.
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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 | Isolated pelvis perfusion |
|---|---|
| Sponsor | Gustave Roussy, Cancer Campus, Grand Paris |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This is a regional chemotherapy delivery technique that isolates the blood supply to the pelvis and perfuses chemotherapeutic agents directly into the isolated vascular bed. By limiting drug exposure to the target region, the approach allows for higher local drug concentrations while reducing systemic toxicity. It is typically used for advanced pelvic malignancies that are unresectable or at high risk of recurrence.
Approved indications
- Advanced pelvic malignancies (sarcoma, gynecologic cancers, colorectal cancer)
- Locally advanced or unresectable pelvic tumors
Common side effects
- Limb toxicity / lower extremity complications
- Hematologic toxicity
- Renal toxicity
- Vascular complications
Key clinical trials
- Study Comparing Isolated Pelvic Perfusion With TNF-α 0.3 mg and Melphalan 1.5 mg/kg Versus Standard Treatment in Patients With Non Resectable, Recurrent Gynaecologic or Digestive Pelvic Cancer (PHASE3)
- Isolated Pelvic and Limb Perfusion in the Treatment of Locally Advanced Sarcoma of Pelvis and Limbs' Girdle (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:
- Isolated pelvis perfusion CI brief — competitive landscape report
- Isolated pelvis perfusion updates RSS · CI watch RSS
- Gustave Roussy, Cancer Campus, Grand Paris portfolio CI
Frequently asked questions about Isolated pelvis perfusion
What is Isolated pelvis perfusion?
How does Isolated pelvis perfusion work?
What is Isolated pelvis perfusion used for?
Who makes Isolated pelvis perfusion?
What development phase is Isolated pelvis perfusion in?
What are the side effects of Isolated pelvis perfusion?
Related
- Manufacturer: Gustave Roussy, Cancer Campus, Grand Paris — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced pelvic malignancies (sarcoma, gynecologic cancers, colorectal cancer)
- Indication: Drugs for Locally advanced or unresectable pelvic tumors
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing