DATROWAY

(Datopotamab deruxtecan)

ApprovedAntibody–drug conjugate

This drug is used to treat certain types of lung cancer and breast cancer by targeting and killing cancer cells that have specific proteins on their surface.[2] DATROWAY is currently approved and in use across 18 indications[4].[1]

DATROWAY is one of 373 antibody-drug conjugate programs targeting Breast Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

372

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Breast CancerRecruiting

Lung CancerRecruiting

Breast NeoplasmUnknown

Metastatic Non Small Cell Lung CancerActive, not recruiting

Non-Small Cell Lung Cancer (NSCLC)Recruiting

Carcinoma, Non-Small-Cell LungActive, not recruiting

Advanced Solid MalignanciesRecruiting

StomatitisRecruiting

Solid TumorRecruiting

Advanced or Metastatic NSCLCActive, not recruiting

Breast CancerPhase 2

Recruiting

Lung CancerPhase 3

Recruiting

Breast NeoplasmPreclinical

Unknown

Metastatic Non Small Cell Lung CancerPhase 3

Active, not recruiting

Non-Small Cell Lung Cancer (NSCLC)Phase 3

Recruiting

Carcinoma, Non-Small-Cell LungPreclinical

Active, not recruiting

Advanced Solid MalignanciesPreclinical

Recruiting

StomatitisApproved

Recruiting

Solid TumorPreclinical

Recruiting

Advanced or Metastatic NSCLCPhase 1

Active, not recruiting

Showing 10 of 18 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

DATROWAY

Daiichi Sankyo

Approved

3 2

Lexiscan

Astellas

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Zolymbus

AbbVie

Preclinical

1 5

Blenoxane

Bristol-Myers Squibb

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

Duragesic-100

CCephalon

Preclinical

2 9

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 10

Spravato

WWim Janssens

Preclinical

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

Timeline

Expected Milestones

Q1 2027

PreclinicalActive, not recruiting

Triple Negative Breast Neoplasms

NCT03742102

Q2 2027

Phase 1Active, not recruiting

Advanced or Metastatic NSCLC

NCT04612751

PreclinicalActive, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT05460273

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT06564844

Q4 2027

Phase 2Recruiting

Endometrial Cancer

NCT05489211

Phase 3Active, not recruiting

Genomic Alterations

NCT05687266

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Datopotamab Deruxtecan (Dato-DXd) for Non-Small Cell Lung Cancer (NSCLC) Patients With Active Brain Metastases

Withdrawn·MMedSIR·Phase 2·NCT06676917

Datopotamab Deruxtecan (Dato-DXd) in Combination With Pembrolizumab With or Without Platinum Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-Lung02)

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT04526691·145 enrolled

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants With Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06350097·582 enrolled

Show 2 more trials

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06564844·25 enrolled

A Phase III, Randomised, Open-label, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Pembrolizumab Monotherapy for the First-line Treatment of Participants With Locally-advanced or Metastatic Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations (TROPION-Lung10)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06357533·675 enrolled

Breast Cancer3 trials

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

Recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT01042379·5,000 enrolled

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-negative (HER2-low or HER2-0) Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy

Recruiting·AAna C Garrido-Castro, MD·Phase 2·NCT06533826·357 enrolled

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Recruiting·NNancy Lin, MD·Phase 2·NCT06176261·58 enrolled

Triple-Negative Breast Cancer2 trials

Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer

Recruiting·QQueen Mary University of London·Phase 2·NCT06954480·140 enrolled

Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases

Recruiting·MMedical University of Vienna·Phase 2·NCT05866432·20 enrolled

Lung Cancer2 trials

Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03944772·247 enrolled

A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)

Recruiting·LLatin American Cooperative Oncology Group·Phase 2·NCT06822543·46 enrolled

Metastatic Non Small Cell Lung Cancer2 trials

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT05215340·740 enrolled

A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT05555732·1,170 enrolled

14 more indications

Genomic Alterations1 trial

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05687266·1,350 enrolled

Residual Disease1 trial

PREDICT-RD: ctDNA Surveillance in TNBC With Residual Disease

Recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT07069595·78 enrolled

NSCLC1 trial

Medical Access Program for Datopotamab Deruxtecan in EGFRm NSCLC Patients

Approved for marketing· Daiichi Sankyo logo

Daiichi Sankyo··NCT06279728

Metastatic Pancreatic Adenocarcinoma1 trial

An Umbrella Clinical Trial of Antibody/Peptide-Drug Conjugates Matched by Mass Spectrometry-Based Absolute Quantitation of Proteins in Locally Advanced or Metastatic Pancreatic or Breast Cancer

Not yet recruiting·FFudan University·Phase 2·NCT07825753·225 enrolled

Non-small Cell Lung Cancer (NSCLC)1 trial

A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07291037·400 enrolled

Stomatitis1 trial

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)

Recruiting· AstraZeneca logo

AstraZeneca·Approved·NCT07357597·100 enrolled

Hormone-receptor-positive Breast Cancer1 trial

Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors (TROPION-PanTumor01)

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03401385·890 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

Phase 1/2, Multicentre, Open-label, Multiple-cohort Study of Dato-DXd in Chinese Patients With Advanced Non-small-cell Lung Cancer, Triple-negative Breast Cancer, Gastric/Gastroesophageal Junction Cancer, Urothelial Cancer, and Other Solid Tumours (TROPION-PanTumor02)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT05460273·119 enrolled

Solid Tumor1 trial

PRIMROSE: A Modular Phase I/IIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced/Metastatic Solid Tumors That Are MTAP Deficient

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT06130553·334 enrolled

Endometrial Cancer1 trial

A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05489211·454 enrolled

Advanced Solid Malignancies1 trial

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT05417594·695 enrolled

Triple Negative Breast Neoplasms1 trial

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT03742102·243 enrolled

Breast Carcinoma1 trial

A Open-label, Multicenter Phase Ib/Ⅱ Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GB268 for Injection as Monotherapy or in Combination Regimens in Patients With Locally Advanced Unresectable or Metastatic Breast Cancer

Not yet recruiting·EEddingpharm (Zhuhai) Co., Ltd.·Preclinical·NCT07738341·270 enrolled

Advanced or Metastatic NSCLC1 trial

A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT04612751·155 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 17, 2025

DATROWAY

BLA BLA761394

Jan 17, 2025

DATROWAY

NDA BLA761394

May 22, 2026

DATROWAY

NDA BLA761394

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Datopotamab deruxtecan. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — DATROWAY drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Datopotamab deruxtecan compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Datopotamab deruxtecan. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761394). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Datopotamab deruxtecan. U.S. National Library of Medicine.
[7]
SEC EDGAR — Daiichi Sankyo company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: TROP2 ADC[3]
Modality: Antibody–drug conjugate[3]
Highest Phase: Approved[1]
Company: Daiichi Sankyo

Key Publications[6]

Datopotamab Deruxtecan in Previously Treated Advanced NSCLC: TROPION-Lung01

N Engl J MedOct 21, 2023DOI: 10.1056/NEJMoa2309529

DATROWAY

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Breast Cancer3 trials

Triple-Negative Breast Cancer2 trials

Lung Cancer2 trials

Metastatic Non Small Cell Lung Cancer2 trials

Genomic Alterations1 trial

Residual Disease1 trial

NSCLC1 trial

Metastatic Pancreatic Adenocarcinoma1 trial

Non-small Cell Lung Cancer (NSCLC)1 trial

Stomatitis1 trial

Hormone-receptor-positive Breast Cancer1 trial

Carcinoma, Non-Small-Cell Lung1 trial

Solid Tumor1 trial

Endometrial Cancer1 trial

Advanced Solid Malignancies1 trial

Triple Negative Breast Neoplasms1 trial

Breast Carcinoma1 trial

Advanced or Metastatic NSCLC1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

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