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intensive chemotherapy
intensive chemotherapy is a Chemotherapy Small molecule drug developed by University Hospital, Toulouse. It is currently in Phase 3 development for Treatment of various types of cancer, including leukemia, lymphoma, and solid tumors.
Intensive chemotherapy involves the use of high doses of chemotherapy drugs to kill cancer cells.
Intensive chemotherapy involves the use of high doses of chemotherapy drugs to kill cancer cells. Used for Treatment of various types of cancer, including leukemia, lymphoma, and solid 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 | intensive chemotherapy |
|---|---|
| Sponsor | University Hospital, Toulouse |
| Drug class | Chemotherapy |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This approach is often used to treat advanced or aggressive cancers, and can involve a combination of different chemotherapy agents. The goal is to induce a complete or partial remission, or to control symptoms and improve quality of life.
Approved indications
- Treatment of various types of cancer, including leukemia, lymphoma, and solid tumors
Common side effects
- Nausea and vomiting
- Fatigue
- Hair loss
- Infection
- Anemia
Key clinical trials
- BLAST MRD AML-2: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 2- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Azacitidine and Venetoclax as Frontline Therapy in Unfit Patients With Acute Myeloid Leukemia (PHASE2)
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Stage II-III Rectal Cancer (PHASE2)
- Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults (PHASE3)
- BLAST MRD AML-1: BLockade of PD-1 Added to Standard Therapy to Target Measurable Residual Disease in Acute Myeloid Leukemia 1- A Randomized Phase 2 Study of Anti-PD-1 Pembrolizumab in Combination With Intensive Chemotherapy as Frontline Therapy in Patients With Acute Myeloid Leukemia (PHASE2)
- CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics (PHASE2)
- VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML (PHASE3)
- Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation (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:
- intensive chemotherapy CI brief — competitive landscape report
- intensive chemotherapy updates RSS · CI watch RSS
- University Hospital, Toulouse portfolio CI
Frequently asked questions about intensive chemotherapy
What is intensive chemotherapy?
How does intensive chemotherapy work?
What is intensive chemotherapy used for?
Who makes intensive chemotherapy?
What drug class is intensive chemotherapy in?
What development phase is intensive chemotherapy in?
What are the side effects of intensive chemotherapy?
Related
- Drug class: All Chemotherapy drugs
- Manufacturer: University Hospital, Toulouse — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Treatment of various types of cancer, including leukemia, lymphoma, and solid tumors
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing