BLAIV (INFUSION)INJECTABLE
Approved
Jan 2025
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
2/8 — Basic
Drug data last refreshed 2d ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DATROWAY (datopotamab deruxtecan) is an antibody-drug conjugate (ADC) approved by the FDA on January 17, 2025. It represents a targeted oncology therapy leveraging Daiichi Sankyo's expertise in ADC technology. Specific indications and mechanism details are under commercial development.
Growth
Early-stage growth asset with limited current commercial footprint; expect rapid team expansion post-launch as market adoption accelerates.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -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.
Started Feb 2026
100 enrolled
Stomatitis
Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations
Started Oct 2025
400 enrolled
Non-small Cell Lung Cancer (NSCLC)
Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer
Started Oct 2025
140 enrolled
Triple Negative Breast Cancer
A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)
Started Sep 2025
46 enrolled
Lung CancerNon Small Cell Lung CancerBrain Metastases
Study of Datopotamab Deruxtecan Plus Carboplatin or Cisplatin Versus Gemcitabine Plus Carboplatin or Cisplatin in Participants With Locally Advanced or Metastatic Urothelial Carcinoma
Started Sep 2025
630 enrolled
Urothelial CancerBladder Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.