Drug · Adc
Trastuzumab Emtansine
CI-DRUG-00000609Explore in graph →NCIt C82492 CHEMBL1743082 CIViC Approved
Regulatory
Approvals (8)
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
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as KADCYLA (DIN 02473224) under ATC L01FD03 TRASTUZUMAB EMTANSINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Oct 24, 2018 | health-canada-dpd |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 14 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 | 41 | 16 | 31 | 120 | 8 | CA, EU, US | Feb 22, 2013 | 2006-04 |
| Malignant Breast Neoplasm | Approved | Phase 4 | 25 | 10 | 26 | 88 | 3 | EU, US | Feb 22, 2013 | 2006-04 |
| Malignant Gastric Neoplasm | Phase3 | Phase 3 | 2 | 1 | 1 | 5 | 0 | — | — | Sep 3, 2012 |
| Malignant Ovarian Neoplasm | Phase2 | Phase 2 | 3 | 0 | 0 | 4 | 0 |
Curated evidence
Clinical evidence (19)
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
- 24793816
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| ERBB2 Amplification7 | ||||||||
| Trastuzumab Emtansine | ||||||||
Clinical trials
Trials with this intervention (126)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT02390427 | Phase Ib Dose-escalation Trial of Taselisib (GDC-0032) in Combination With Anti-HER2 Therapies in Participants With Advanced HER2+ Breast Cancer | completed | Phase 1 | 68 | Nancy Lin, MDOTHER | 1 | Sep 24, 2026 | clinicaltrials |
| NCT07825753 | Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer(PROBE) | not yet recruiting |