Brand Name

Datroway

Generic Name
Datopotamab Deruxtecan
View Brand Information
FDA approval date: January 17, 2025
Form: Injection

What is Datroway (Datopotamab Deruxtecan)?

DATROWAY is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of: adult patients with locally advanced or metastatic epidermal growth factor receptor -mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy.

Approved To Treat

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Related Clinical Trials

A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)
A Randomized, Open-Label, Phase 2/3 Study of Datopotamab Deruxtecan (Dato-DXd) Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) Who Progressed During or After Enfortumab Vedotin (EV) Plus Pembrolizumab Combination Treatment TROPION-Urothelial03 (TU03)
Enrollment Status: Recruiting
Publish Date: December 05, 2025
Intervention Type: Drug
Study Phase: Phase 2/Phase 3

Summary: This is a global, multicenter, randomized, open-label, Phase 2/3 study of Dato-DXd plus carboplatin or cisplatin versus gemcitabine plus carboplatin or cisplatin in participants with la/mUC who progressed during or after EV plus pembrolizumab combination treatment. This trial will start with part A, Phase 2. During part A, Phase 2, preliminary efficacy and safety will be assessed, and the recommen...

A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)
A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)
Who is this study for: Patients with resectable, early-stage non-small cell lung cancer
Enrollment Status: Recruiting
Publish Date: December 01, 2025
Intervention Type: Drug
Study Drugs: Durvalumab, Oleclumab, Monalizumab
Study Phase: Phase 2

Summary: The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab, Monalizumab, or AZD0171 and platinum doublet chemotherapy (CTX); or Volrustomig or Rilvegostomig in combination with CTX; or Datopotamab deruxtecan (Dato-DXd) in combination with Durvalumab or Rilvegostomig and single agent platinum chemotherapy in participants with res...

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)
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)
Enrollment Status: Recruiting
Publish Date: November 24, 2025
Intervention Type: Drug
Study Phase: Phase 1/Phase 2

Summary: This study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AZD9574 individually and in combination with anti-cancer agents in participants with advanced cancer that has recurred/progressed.

View All Clinical Trials

Related Latest Advances

Targeting TROP2 Across Solid Tumors: The Clinical Profile and Role of Datopotamab Deruxtecan.
Targeting TROP2 Across Solid Tumors: The Clinical Profile and Role of Datopotamab Deruxtecan.
Journal: The Annals of pharmacotherapy
Published: December 01, 2025
Datopotamab deruxtecan versus docetaxel for non-small cell lung cancer: a plain language summary of the TROPION-Lung01 study.
Datopotamab deruxtecan versus docetaxel for non-small cell lung cancer: a plain language summary of the TROPION-Lung01 study.
Journal: Future oncology (London, England)
Published: November 21, 2025
Efficacy and Safety of Antibody Drug Conjugates in Previously Treated Hormone Receptor Positive HER2 Negative (or Low) Metastatic Breast Cancer-A Systematic Review and Meta-Analysis.
Efficacy and Safety of Antibody Drug Conjugates in Previously Treated Hormone Receptor Positive HER2 Negative (or Low) Metastatic Breast Cancer-A Systematic Review and Meta-Analysis.
Journal: American journal of clinical oncology
Published: October 14, 2025
View All Latest Advances

Brand Information

DATROWAY (Datopotamab Deruxtecan)
1DOSAGE FORMS AND STRENGTHS
For injection: 100 mg of datopotamab deruxtecan-dlnk as a white to yellowish white, lyophilized powder in a single-dose vial for reconstitution and further dilution.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Interstitial Lung Disease/Pneumonitis
  • Ocular Adverse Reactions
  • Stomatitis
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The pooled safety population described in WARNINGS AND PRECAUTIONS reflects exposure to DATROWAY in 927 patients as a single agent at 6 mg/kg administered as an intravenous infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. This included 137 patients with NSCLC in TROPION-Lung05
4DESCRIPTION
Datopotamab deruxtecan-dlnk is a Trop-2-directed antibody and topoisomerase inhibitor conjugate. Datopotamab deruxtecan-dlnk is an antibody-drug conjugate (ADC) composed of three components: 1) a humanized anti-Trop-2 IgG1 monoclonal antibody (mAb), covalently linked to 2) a topoisomerase I inhibitor, via 3) a tetrapeptide-based cleavable linker. Deruxtecan is composed of a protease-cleavable maleimide tetrapeptide linker and the topoisomerase inhibitor, DXd, which is an exatecan derivative.
The antibody is produced in Chinese hamster ovary cells by recombinant DNA technology, and the topoisomerase inhibitor and linker are produced by chemical synthesis. Approximately 4 molecules of deruxtecan are attached to each antibody molecule. Datopotamab deruxtecan-dlnk has the following structure:
Chemical Structure
DATROWAY (datopotamab deruxtecan-dlnk) for injection is a sterile, white to yellowish white, preservative-free lyophilized powder in single-dose vials. Each vial delivers 100 mg of datopotamab deruxtecan-dlnk, L-histidine (3.88 mg), L-histidine hydrochloride monohydrate (5.25 mg), polysorbate 80 (1.50 mg), and sucrose (450 mg). Following reconstitution with 5 mL of Sterile Water for Injection, USP, the resulting concentration of datopotamab deruxtecan-dlnk is 20 mg/mL with a pH of 6.0. The resulting solution is administered by intravenous infusion following dilution.
5REFERENCES
  1. OSHA Hazardous Drugs.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
7PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton
NDC 65597-801-01
DATROWAY
100 mg per vial
For Intravenous Infusion Only
Reconstitute and dilute prior to administration.
Single-dose vial. Discard unused portion.
Dispense the enclosed Medication Guide to
Hazardous Drug
KEEP REFRIGERATED
Daiichi-Sankyo
PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton