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Preoperative chemotherapy
Preoperative chemotherapy is a Small molecule drug developed by CNAO National Center of Oncological Hadrontherapy. It is currently in Phase 3 development for Reduction of tumor size before surgery. Also known as: Folinic acid, Irinotecan, fluorouracil, oxaliplatin, neoadjuvant chemotherapy, doxorubicin+cyclophosphamide and paclitaxel.
Preoperative chemotherapy involves administering chemotherapy before surgery to reduce tumor size and improve surgical outcomes.
Preoperative chemotherapy involves administering chemotherapy before surgery to reduce tumor size and improve surgical outcomes. Used for Reduction of tumor size before surgery.
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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 | Preoperative chemotherapy |
|---|---|
| Also known as | Folinic acid, Irinotecan, fluorouracil, oxaliplatin, neoadjuvant chemotherapy, doxorubicin+cyclophosphamide and paclitaxel |
| Sponsor | CNAO National Center of Oncological Hadrontherapy |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This approach aims to make the surgery less invasive and reduce the risk of cancer recurrence. Chemotherapy is typically administered over several weeks or months before the scheduled surgery.
Approved indications
- Reduction of tumor size before surgery
Common side effects
- Nausea
- Fatigue
- Hair loss
- Anemia
- Infection
Key clinical trials
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Stage II-III Rectal Cancer (PHASE2)
- Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer (PHASE2, PHASE3)
- Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE) (PHASE2)
- Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery (PHASE2, PHASE3)
- Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC (PHASE3)
- Neoadjuvant Chemotherapy Before Surgery vs Surgery Alone for UTUC: A Randomized Trial (PHASE2)
- Duration of Cardiac Antimicrobial Prophylaxis Outcomes Study (PHASE4)
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:
- Preoperative chemotherapy CI brief — competitive landscape report
- Preoperative chemotherapy updates RSS · CI watch RSS
- CNAO National Center of Oncological Hadrontherapy portfolio CI
Frequently asked questions about Preoperative chemotherapy
What is Preoperative chemotherapy?
How does Preoperative chemotherapy work?
What is Preoperative chemotherapy used for?
Who makes Preoperative chemotherapy?
Is Preoperative chemotherapy also known as anything else?
What development phase is Preoperative chemotherapy in?
What are the side effects of Preoperative chemotherapy?
Related
- Manufacturer: CNAO National Center of Oncological Hadrontherapy — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Reduction of tumor size before surgery
- Also known as: Folinic acid, Irinotecan, fluorouracil, oxaliplatin, neoadjuvant chemotherapy, doxorubicin+cyclophosphamide and paclitaxel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing