Drug · Adc
Trastuzumab Deruxtecan
CI-DRUG-00000607Explore in graph →NCIt C152716 CHEMBL4297844 CIViC Approved
Regulatory
Approvals (21)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-11
- Retrieved
- Sep 14, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260914-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2026-05-15 (see label) | approved | May 15, 2026 | openfda |
| US FDA | — | Efficacy supplement 2026-05-15 (see label) | approved | May 15, 2026 | openfda |
| US FDA | — | Efficacy supplement 2026-04-27 (see label) | approved | Apr 27, 2026 | openfda |
| US FDA | — | Efficacy supplement 2025-12-15 (see label) | approved | Dec 15, 2025 | openfda |
| US |
Data updated 16 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 | — | 0 | 0 | 0 | 0 | 21 | US | Dec 20, 2019 | — |
| Malignant Breast Neoplasm | Approved | — | 0 | 0 | 0 | 0 | 6 | US | Dec 20, 2019 | — |
| Malignant Lung Neoplasm | Approved | — | 0 | 0 | 0 | 0 | 1 | US | Dec 20, 2019 | — |
Curated evidence
Clinical evidence (3)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 31047803
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| ERBB2 Amplification2 | ||||||||
| Trastuzumab Deruxtecan | ||||||||
Clinical trials
Trials with this intervention (0)
Data not yet available