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Dinutuximab. Immunotherapy
Dinutuximab. Immunotherapy is a Monoclonal antibody Small molecule drug developed by Fundació Sant Joan de Déu. It is currently in Phase 2 development for Neuroblastoma. Also known as: Ch14.18, Sargramostim, GM-CSF, Isotretinoin.
Monoclonal antibody targeting GD2
Monoclonal antibody targeting GD2 Used for Neuroblastoma.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Dinutuximab. Immunotherapy |
|---|---|
| Also known as | Ch14.18, Sargramostim, GM-CSF, Isotretinoin, 13-cis-retinoic acid, or RA |
| Sponsor | Fundació Sant Joan de Déu |
| Drug class | Monoclonal antibody |
| Target | GD2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Dinutuximab is a chimeric monoclonal antibody that targets the disialoganglioside GD2, a glycosphingolipid present on the surface of neuroblastoma cells.
Approved indications
- Neuroblastoma
Common side effects
- Fatigue
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
Key clinical trials
- NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial (PHASE2)
- Immunotherapy of Relapsed Refractory Neuroblastoma With Expanded NK Cells (PHASE1)
- Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (PHASE3)
- Pediatric Precision Laboratory Advanced Neuroblastoma Therapy (PHASE2)
- Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (PHASE1)
- Quadruple Immunotherapy for Neuroblastoma (PHASE2)
- Study Combining Dinutuximab Beta With Two Chemotherapy Regimens in Neuroblastoma (PHASE1)
- High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN) (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:
- Dinutuximab. Immunotherapy CI brief — competitive landscape report
- Dinutuximab. Immunotherapy updates RSS · CI watch RSS
- Fundació Sant Joan de Déu portfolio CI
Frequently asked questions about Dinutuximab. Immunotherapy
What is Dinutuximab. Immunotherapy?
How does Dinutuximab. Immunotherapy work?
What is Dinutuximab. Immunotherapy used for?
Who makes Dinutuximab. Immunotherapy?
Is Dinutuximab. Immunotherapy also known as anything else?
What drug class is Dinutuximab. Immunotherapy in?
What development phase is Dinutuximab. Immunotherapy in?
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What does Dinutuximab. Immunotherapy target?
Related
- Drug class: All Monoclonal antibody drugs
- Target: All drugs targeting GD2
- Manufacturer: Fundació Sant Joan de Déu — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Neuroblastoma
- Also known as: Ch14.18, Sargramostim, GM-CSF, Isotretinoin, 13-cis-retinoic acid, or RA
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing