Drug · Adc

Datopotamab Deruxtecan

CI-DRUG-00000180Explore in graph →NCIt C151967 CHEMBL4297939 CIViC Phase 3

Regulatory

Approvals (5)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory5 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Malignant Breast Neoplasm	Breast cancerDatroway 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.	approved	Apr 4, 2025	ema
US FDA	—	Efficacy supplement 2026-05-22 (see label)	approved	May 22, 2026	openfda
US FDA	Lung Non-Small Cell Carcinoma with EGFR Mutation	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.	approved	Jan 17, 2025	openfda
US FDA	Triple-Negative Breast Carcinoma

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	44	23	17	46	5	EU, US	Jan 17, 2025	Mar 1, 2010
Malignant Lung Neoplasm	Approved	Phase 3	21	8	9	23	1	US	Jan 17, 2025	Jan 31, 2018
Malignant Breast Neoplasm	Approved	Phase 3	18	9	6	18	3	EU, US	Jan 17, 2025	Mar 1, 2010
Malignant Bladder Neoplasm	Phase3	Phase 3	2	1	1	2	0

Curated evidence

Clinical evidence (1)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–1 of 1 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
EGFR Mutation1
Datopotamab Deruxtecan

Clinical trials

Trials with this intervention (48)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–48 of 48 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06103864	A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)	recruiting	Phase 3	625	AstraZenecaINDUSTRY	24	Sep 25, 2026	clinicaltrials
NCT05215340	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

Molecule

Record

Kind: Adc
Mechanism: Tumor-associated calcium signal transducer 2 binding agent; DNA topoisomerase I inhibitor
Targets: 2 genes
UNII: GD2OWY1DTK
Aliases: ADC DS-1062a, ADC DS-1062A, Anti-TROP2/DXd Antibody-drug Conjugate DS-1062a, Dato-DXd, Datopotamab Deruxtecan, Datopotamab Deruxtecan-dlnk, Datroway, DATROWAY, DS 1062, DS-1062, DS1062, DS-1062a

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (2)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01FX35	Antineoplastic agents
EMA product	EMEA/H/C/006547	Datroway

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.