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Datroway

datopotamab deruxtecan
TROP2-Directed ADC FDA Approved 2025 Daiichi Sankyo
Route
IV
Half-Life
~5 days
FDA Approved
2025
Manufacturer
Daiichi Sankyo
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1. Indications and Usage

Non-squamous NSCLC after prior therapy.

2. Dosage and Administration

6 mg/kg IV Q3W.

3. Dosage Forms and Strengths

Injection

4. Contraindications

None listed.

5. Warnings and Precautions
  • ILD/Pneumonitis: Fatal. Discontinue.
  • Ocular Toxicity: Monitor.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Stomatitis (55%), Nausea (50%), Fatigue (36%), Rash (32%), Alopecia (31%), Dry Eye (30%)

Stomatitis
55%
Nausea
50%
Fatigue
36%
Rash
32%
Alopecia
31%
Dry Eye
30%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

CYP3A inhibitors may increase DXd.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

TROP2-directed ADC with topoisomerase I inhibitor DXd.

Pharmacokinetics

DXd t1/2: ~5.8 days.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Datroway Trials on ClinicalTrials.gov ↗ 📚 PubMed: Datroway Clinical Trials ↗
FDA-Approved Tumor Types

Datroway has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

NSCLC
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Datroway. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Datroway (datopotamab deruxtecan) approved for?

Datroway (datopotamab deruxtecan) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Datroway (datopotamab deruxtecan) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Datroway (datopotamab deruxtecan) work?

TROP2-directed ADC with topoisomerase I inhibitor DXd.

What are the most common side effects?

Stomatitis (55%), Nausea (50%), Fatigue (36%), Rash (32%), Alopecia (31%), Dry Eye (30%) Stomatitis 55% Nausea 50% Fatigue 36% Rash 32% Alopecia 31% Dry Eye 30%

← All Therapies Full Prescribing Information ↗