MedPath

Datopotamab deruxtecan

Generic Name
Datopotamab deruxtecan
Brand Names
Datroway
Drug Type
Biotech
CAS Number
2238831-60-0
Unique Ingredient Identifier
GD2OWY1DTK

Overview

Datopotamab deruxtecan is under investigation in clinical trial NCT04656652 (Study of DS-1062A Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-LUNG01)).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
2025/02/12
NCT06822543
Phase 2
Not yet recruiting
Latin American Cooperative Oncology Group
Datopotamab Deruxtecan (Dato-DXd) for Non-Small Cell Lung Cancer (NSCLC) Patients with Active Brain Metastases
2024/11/06
NCT06676917
Phase 2
Not yet recruiting
MedSIR
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
2024/08/21
NCT06564844
Phase 3
Recruiting
AstraZeneca
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
2024/08/01
NCT06533826
Phase 2
Recruiting
Ana C Garrido-Castro, MD
A Study to Explore Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of Novel Therapeutics in Patients With Early Relapsed Metastatic Triple-negative Breast Cancer
2024/07/18
NCT06508216
Phase 1
Recruiting
Gustave Roussy, Cancer Campus, Grand Paris
A trial to learn how safe Dato-DXd is and how well it works in people with NSCLC that has advanced after receiving osimertinib
2024/11/07
2024-511362-37-00
Phase 3
Recruiting
AstraZeneca AB
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
2024/04/10
NCT06357533
Phase 3
Recruiting
AstraZeneca
A trial to learn how safe Dato-DXd is when given with osimertinib, and how well it works compared to osimertinib alone in people who have advanced or metastatic non-small cell lung cancer (NSCLC) with a mutation in the EGFR gene
2024/04/05
2023-509883-89-00
Phase 3
Recruiting
AstraZeneca AB
Medical Access Program for Datopotamab Deruxtecan in EGFRm NSCLC Patients
2024/02/28
NCT06279728
N/A
APPROVED_FOR_MARKETING
Daiichi Sankyo
A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors
2025/06/24
2024-516916-93-00
Phase 1
Not yet recruiting
Daiichi Sankyo Inc.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
DATROWAY
Daiichi Sankyo Inc.
65597-801
INTRAVENOUS
100 mg in 5 mL
5/21/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
DATROWAY POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/VIAL
Baxter Oncology GmbH
SIN17234P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
100 mg/vial
5/10/2025

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
DATROWAY datopotamab deruxtecan 100 mg powder for injection vial
444066
AstraZeneca Pty Ltd
Medicine
A
5/20/2025

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