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Allogeneic bone marrow transplantation
Allogeneic bone marrow transplantation is a Cell therapy / Hematopoietic stem cell transplantation Biologic drug developed by Medical College of Wisconsin. It is currently in Phase 3 development for Acute myeloid leukemia, Acute lymphoblastic leukemia, Chronic myeloid leukemia.
Allogeneic bone marrow transplantation replaces a patient's diseased or damaged bone marrow with healthy hematopoietic stem cells from a matched donor to restore normal blood cell production and immune function.
Allogeneic bone marrow transplantation involves transplanting bone marrow cells from a genetically non-identical donor to a recipient. This procedure is studied for various conditions, including Acute Biphenotypic Leukemia, Acute Lymphoblastic Leukemia, and Myelodysplastic Syndrome, using interventions such as Dilanubicel, Cyclophosphamide, and Fludarabine.
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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 | Allogeneic bone marrow transplantation |
|---|---|
| Sponsor | Medical College of Wisconsin |
| Drug class | Cell therapy / Hematopoietic stem cell transplantation |
| Modality | Biologic |
| Therapeutic area | Oncology / Hematology / Immunology |
| Phase | Phase 3 |
Mechanism of action
The procedure involves myeloablative or reduced-intensity conditioning to eliminate diseased marrow, followed by infusion of donor-derived hematopoietic stem cells that engraft and reconstitute hematopoiesis. This approach is used to treat hematologic malignancies, severe aplastic anemia, and certain genetic disorders, with therapeutic benefit derived from both the replacement of defective marrow and the graft-versus-tumor/disease effect from donor immune cells.
Approved indications
- Acute myeloid leukemia
- Acute lymphoblastic leukemia
- Chronic myeloid leukemia
- Myelodysplastic syndrome
- Severe aplastic anemia
- Lymphoma
- Multiple myeloma
Common side effects
- Graft-versus-host disease (acute)
- Graft-versus-host disease (chronic)
- Infection
- Mucositis
- Hepatic veno-occlusive disease
- Graft failure or rejection
- Secondary malignancy
Key clinical trials
- Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies (PHASE2)
- Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell) Transplant and as Maintenance Therapy After Transplant in Patients With Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial) (PHASE2)
- 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)
- Allogeneic Hematopoietic Stem Cell Transplantation for Chronic Granulomatous Disease (CGD) With an Alemtuzumab, Busulfan and TBI-based Conditioning Regimen Combined With Cytokine (IL-6, +/- IFN-gamma) Antagonists (PHASE1, PHASE2)
- Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
- A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Mixed Phenotype Acute Leukemia (PHASE1)
- Intensity-Modulated Radiation Therapy, Etoposide, and Cyclophosphamide Followed By Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia (PHASE1, PHASE2)
- Pre-emptive Therapy With DEC-C to Improve Outcomes in MDS Patients With Measurable Residual Disease Post Allogeneic Hematopoietic Cell Transplant (PHASE1, 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:
- Allogeneic bone marrow transplantation CI brief — competitive landscape report
- Allogeneic bone marrow transplantation updates RSS · CI watch RSS
- Medical College of Wisconsin portfolio CI
Frequently asked questions about Allogeneic bone marrow transplantation
What is Allogeneic bone marrow transplantation?
How does Allogeneic bone marrow transplantation work?
What is Allogeneic bone marrow transplantation used for?
Who makes Allogeneic bone marrow transplantation?
What drug class is Allogeneic bone marrow transplantation in?
What development phase is Allogeneic bone marrow transplantation in?
What are the side effects of Allogeneic bone marrow transplantation?
Related
- Drug class: All Cell therapy / Hematopoietic stem cell transplantation drugs
- Manufacturer: Medical College of Wisconsin — full pipeline
- Therapeutic area: All drugs in Oncology / Hematology / Immunology
- Indication: Drugs for Acute myeloid leukemia
- Indication: Drugs for Acute lymphoblastic leukemia
- Indication: Drugs for Chronic myeloid leukemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing