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Datroway

Datopotamab Deruxtecan

Trop-2-directed antibody-drug conjugate. Developed by Daiichi Sankyo. Clinical, regulatory, and source evidence are connected below.

Company
Daiichi Sankyo
Target / MOA
TROP2 · TACSTD2
Aliases
Datroway
Signals
21
Clinical trials
11
Approvals
0
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

Phase 3 · RECRUITING · AstraZeneca

clinical trialClinicalTrials.gov

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

Phase 3 · ACTIVE_NOT_RECRUITING · AstraZeneca

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Datroway · BLA761394 · label version 18, effective May 27, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) DATROWAY is indicated for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. This indication is approved under accelerated approval based on objective response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. 1.2 Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC) DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy [see Clinical Studies (14.2) ]. 1.3 Unresectable or Metastatic, HR-Positive, HER2-Negative Breast Cancer DATROWAY is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

European Union (EMA)

Datroway · EMEA/H/C/006547 · Authorised, authorised Apr 4, 2025 (Commission decision C(2025) 2203) · EPAR

Breast cancer Datroway as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine therapy and at least one line of chemotherapy in the advanced setting.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

BLA761394 · DAIICHI SANKYO INC · first approved Jan 17, 2025

1 efficacy supplement approved

European Union

  • Datroway: Authorised since Apr 4, 2025
  • Jun 25, 2026 · Datroway: CHMP opinion on an extension, positive

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

BLA761394 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies · 11 linked records.

Phase 3RECRUITINGNCT07291037

Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations

AstraZeneca · Updated Oct 13, 2026

Phase 3ACTIVE NOT RECRUITINGNCT05687266

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

AstraZeneca · Updated Oct 9, 2026

Phase 4RECRUITINGNCT07357597

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.

AstraZeneca · Updated Sep 30, 2026

Phase 3ACTIVE NOT RECRUITINGNCT05215340

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

Daiichi Sankyo · Updated Sep 24, 2026

Phase 3RECRUITINGNCT06357533

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

AstraZeneca · Updated Sep 23, 2026

Phase 2RECRUITINGNCT05489211

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

AstraZeneca · Updated Sep 23, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Oct 21, 202620EMA Human Medicinesofficial · Latest Sep 30, 20261
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.