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High Dose Chemotherapy
High Dose Chemotherapy is a Chemotherapy regimen (multi-agent) Small molecule drug developed by Eastern Cooperative Oncology Group. It is currently in Phase 3 development for High-risk or relapsed hematologic malignancies (lymphoma, leukemia, myeloma), Metastatic solid tumors (breast cancer, ovarian cancer, testicular cancer), Conditioning regimen for hematopoietic stem cell transplantation. Also known as: high-dose chemotherapy.
High-dose chemotherapy delivers cytotoxic drugs at elevated concentrations to kill rapidly dividing cancer cells, often followed by stem cell rescue to restore bone marrow function.
High-dose chemotherapy delivers cytotoxic drugs at elevated concentrations to kill rapidly dividing cancer cells, often followed by stem cell rescue to restore bone marrow function. Used for High-risk or relapsed hematologic malignancies (lymphoma, leukemia, myeloma), Metastatic solid tumors (breast cancer, ovarian cancer, testicular cancer), Conditioning regimen for hematopoietic stem cell transplantation.
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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 | High Dose Chemotherapy |
|---|---|
| Also known as | high-dose chemotherapy |
| Sponsor | Eastern Cooperative Oncology Group |
| Drug class | Chemotherapy regimen (multi-agent) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
High-dose chemotherapy regimens exceed standard dosing to maximize tumor cell kill by exploiting dose-response relationships in chemosensitive malignancies. The approach is typically used in hematologic and solid tumors where dose escalation improves response rates. Autologous or allogeneic stem cell transplantation is often employed to mitigate myelosuppression and enable patient recovery.
Approved indications
- High-risk or relapsed hematologic malignancies (lymphoma, leukemia, myeloma)
- Metastatic solid tumors (breast cancer, ovarian cancer, testicular cancer)
- Conditioning regimen for hematopoietic stem cell transplantation
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Mucositis
- Nausea and vomiting
- Infection
- Organ toxicity (cardiac, renal, hepatic)
- Secondary malignancy
Key clinical trials
- BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia (PHASE1)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity (PHASE2)
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (PHASE2)
- Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2 (PHASE3)
- A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia (PHASE1)
- A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia (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:
- High Dose Chemotherapy CI brief — competitive landscape report
- High Dose Chemotherapy updates RSS · CI watch RSS
- Eastern Cooperative Oncology Group portfolio CI
Frequently asked questions about High Dose Chemotherapy
What is High Dose Chemotherapy?
How does High Dose Chemotherapy work?
What is High Dose Chemotherapy used for?
Who makes High Dose Chemotherapy?
Is High Dose Chemotherapy also known as anything else?
What drug class is High Dose Chemotherapy in?
What development phase is High Dose Chemotherapy in?
What are the side effects of High Dose Chemotherapy?
Related
- Drug class: All Chemotherapy regimen (multi-agent) drugs
- Manufacturer: Eastern Cooperative Oncology Group — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for High-risk or relapsed hematologic malignancies (lymphoma, leukemia, myeloma)
- Indication: Drugs for Metastatic solid tumors (breast cancer, ovarian cancer, testicular cancer)
- Indication: Drugs for Conditioning regimen for hematopoietic stem cell transplantation
- Also known as: high-dose chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing