DANYELZA

(Naxitamab)

ApprovedMonoclonal antibody

DANYELZA is one of 84 small molecule programs targeting Metastatic Triple-negative Breast Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Metastatic Triple-Negative Breast CancerRecruiting

High-Risk NeuroblastomaRecruiting

Anatomic Stage IV Breast Cancer AJCC V8Recruiting

Ewing SarcomaRecruiting

NeuroblastomaNot yet recruiting

Metastatic Triple-Negative Breast CancerPreclinical

Recruiting

High-Risk NeuroblastomaPhase 2

Recruiting

Anatomic Stage IV Breast Cancer AJCC V8Preclinical

Recruiting

Ewing SarcomaPhase 2

Recruiting

NeuroblastomaApproved

Not yet recruiting

Competition

Competitive Landscape

88 competitors in Neuroblastoma

#DrugCompanyPhaseTrials

DANYELZA

BBTG International Inc.

Approved

6 2

Vepesid

AAvyxa

Phase 3

40 3

Cytoxan

BBaxter Healthcare Corporation

Phase 3

52 4

Paraplatin

AAvyxa

Phase 3

35 5

Leukine

Sanofi

Phase 3

15 6

Camptosar

Pfizer

Phase 3

12 7

Tepadina

Jazz Pharmaceuticals

Phase 3

11 8

Alkeran

AApotex Inc.

Phase 3

28 9

Accutane

CConrado Roberto Hoffmann Filho

Adriamycin

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Post-ApprovalNot yet recruiting

Neuroblastoma

NCT06047535

Q4 2027

PreclinicalRecruiting

Anatomic Stage IV Breast Cancer AJCC V8

NCT06026657

Phase 1Recruiting

Neuroblastoma

NCT07027748

Q3 2028

Phase 2Recruiting

Ewing Sarcoma

NCT05968768

Q3 2029

Phase 2Recruiting

High-Risk Neuroblastoma

NCT06528496

Clinical

Trials by Indication[1]

Neuroblastoma6 trials

Quadruple Immunotherapy for Neuroblastoma

Recruiting·HHong Kong Children's Hospital·Phase 2·NCT05754684·29 enrolled

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Combined With Isotretinoin for Maintenance Treatment of Patients With High-Risk Neuroblastoma in First Complete Response.

Not yet recruiting·SSciClone Pharmaceuticals·Phase 4·NCT06047535·62 enrolled

Naxitamab and Granulocyte-Macrophage Colony Stimulating Factor (GMCSF) and Isotretinoin for Consolidation of Patients With High-Risk Neuroblastoma in First Remission.

Withdrawn·YY-mAbs Therapeutics·Phase 2·NCT04909515

Show 3 more trials

Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma

Recruiting·GGiselle Sholler·Phase 2·NCT06540963·98 enrolled

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Recruiting·GGiselle Sholler·Phase 2·NCT05489887·93 enrolled

Feasibility Study of Prolonged Administration of Naxitamab, Irinotecan, and Temozolomide for Patients With Relapsed or Refractory Neuroblastoma

Recruiting·SSteven DuBois, MD·Phase 1·NCT07027748·18 enrolled

High-Risk Neuroblastoma2 trials

Phase II Trial of Naxitamab, Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Combination With Induction Chemotherapy for Patients With Newly-Diagnosed High-Risk Neuroblastoma

Recruiting·SShaare Zedek Medical Center·Phase 2·NCT07537400·10 enrolled

N10: Reduced Therapy for High-Risk Neuroblastoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06528496·45 enrolled

Ewing sarcoma1 trial

To Evaluate the Efficacy and Safety of Naxitamab in Patients With Refractory Ewing's Sarcoma

Recruiting·AAnna Raciborska·Phase 2·NCT05968768·24 enrolled

Anatomic Stage IV Breast Cancer AJCC v81 trial

Phase 1b/2 Study of Naxitamab (Danyelza), Gemcitabine and Ex Vivo Expanded Allogenic Universal Donor, TGFβi Natural Killer (NK) Cells in Advanced GD2-expressing Breast Cancers (DiG NKs)

Recruiting·MMargaret Gatti-Mays·Preclinical·NCT06026657·42 enrolled

Metastatic Triple-negative Breast Cancer1 trial

Phase I/II Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT07011654·31 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 25, 2020

DANYELZA

BLA BLA761171

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Naxitamab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Naxitamab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Naxitamab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761171). U.S. Food & Drug Administration.
[5]
SEC EDGAR — BTG International Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Approved[1]
Company: BBTG International Inc.

DANYELZA

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q3 2028

Q3 2029

Trials by Indication[1]

Neuroblastoma6 trials

High-Risk Neuroblastoma2 trials

Ewing sarcoma1 trial

Anatomic Stage IV Breast Cancer AJCC v81 trial

Metastatic Triple-negative Breast Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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