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 13 indications[4].[1]

DATROWAY is one of 307 antibody-drug conjugate programs targeting Lung Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

306

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Lung CancerActive, not recruiting

AdenocarcinomaActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

Breast NeoplasmUnknown

StomatitisRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerUnknown

Solid TumorRecruiting

Non-Small Cell Lung Cancer (NSCLC)Recruiting

Carcinoma, Non-Small-Cell LungActive, not recruiting

Lung CancerPhase 3

Active, not recruiting

AdenocarcinomaPhase 3

Active, not recruiting

Triple-Negative Breast CancerPhase 1/Phase 2

Active, not recruiting

Breast NeoplasmPreclinical

Unknown

StomatitisApproved

Recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Breast CancerPreclinical

Unknown

Solid TumorPreclinical

Recruiting

Non-Small Cell Lung Cancer (NSCLC)Phase 3

Recruiting

Carcinoma, Non-Small-Cell LungPreclinical

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

DATROWAY

Daiichi Sankyo

Approved

4 2

Tykerb

GSK

Preclinical

80 3

Halaven

Eisai

Preclinical

38 4

Avastin

BBio-Thera Solutions

Preclinical

153 5

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 6

Prolia

Amgen

Preclinical

14 7

Voltaren

Novartis

Preclinical

1 8

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 9

Spravato

WWim Janssens

Preclinical

2 10

Zinecard

CChildren's Oncology Group

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Advanced Solid Tumors

NCT03401385

Phase 1/2Active, not recruiting

Breast Cancer

NCT03742102

Q2 2027

Phase 3Active, not recruiting

Adenocarcinoma

NCT06564844

PreclinicalActive, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT05460273

Q4 2027

Phase 2Recruiting

Advanced Solid Tumours

NCT05489211

Phase 3Active, not recruiting

Genomic Alterations

NCT05687266

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

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 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

Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06350097·582 enrolled

Show 2 more trials

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

Withdrawn·MMedSIR·Phase 2·NCT06676917

Phase 1b Study of Dato-DXd in Combination With Immunotherapy With or Without Carboplatin in Advanced or Metastatic Non-Small Cell Lung Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT04612751·155 enrolled

Breast Cancer4 trials

DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Recruiting·—·Phase 2·NCT06176261·58 enrolled

TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd

Recruiting·—·Phase 2·NCT06533826·357 enrolled

A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT03742102·243 enrolled

Show 1 more trial

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

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

Genomic Alterations2 trials

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06357533·675 enrolled

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

Advanced Solid Tumours1 trial

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05489211·454 enrolled

12 more indications

Advanced or Metastatic NSCLC1 trial

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 3·NCT05215340·740 enrolled

Advanced Solid Tumors1 trial

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

Active, not recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03401385·890 enrolled

Lung Cancer1 trial

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

Adenocarcinoma1 trial

A Phase III, Randomised Study of Adjuvant Dato-DXd in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma NSCLC Who Are ctDNA-positive or Have High-risk Pathological Features

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06564844·24 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

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

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

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

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

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

Metastatic Non Small Cell Lung Cancer1 trial

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

Regulatory

FDA Approval Timeline[5]

Jan 17, 2025

DATROWAY

BLA BLA761394

Sources

References

[1]
ClinicalTrials.gov — 26 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 (BLA 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 Cancer4 trials

Triple-Negative Breast Cancer2 trials

Genomic Alterations2 trials

Advanced Solid Tumours1 trial

Advanced or Metastatic NSCLC1 trial

Advanced Solid Tumors1 trial

Lung Cancer1 trial

Adenocarcinoma1 trial

Residual Disease1 trial

NSCLC1 trial

Solid Tumor1 trial

Stomatitis1 trial

Advanced Solid Malignancies1 trial

Carcinoma, Non-Small-Cell Lung1 trial

Non-small Cell Lung Cancer (NSCLC)1 trial

Metastatic Non Small Cell Lung Cancer1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News