Drug Type Antibody drug conjugate (ADC) |
Synonyms Fam-trastuzumab deruxtecan, T-DXd, Trastuzumab deruxtecan + [14] |
Target |
Action antagonists, inhibitors |
Mechanism HER2 antagonists(Receptor tyrosine-protein kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (20 Dec 2019), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), SAKIGAKE (Japan), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Fam-trastuzumab deruxtecan-NXKI |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HER2 Positive Solid Tumors | United Kingdom | 09 Apr 2025 | |
HR-positive/HER2-low Breast Carcinoma | United States | 28 Jan 2025 | |
Hormone receptor positive HER2 positive breast cancer | South Korea | 19 Sep 2022 | |
HER2 mutant non-small cell lung cancer | United States | 11 Aug 2022 | |
HER2 Positive Stomach Adenocarcinoma | Australia | 08 Oct 2021 | |
HER2-Low Breast Carcinoma | Australia | 08 Oct 2021 | |
Metastatic breast cancer | Canada | 15 Apr 2021 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | United States | 15 Jan 2021 | |
HER2-positive gastric cancer | Japan | 25 Sep 2020 | |
HER2 Positive Breast Cancer | United States | 20 Dec 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Non-squamous non-small cell lung cancer | Phase 3 | - | 07 Sep 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | United States | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | China | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Japan | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Argentina | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Belgium | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Brazil | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Chile | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | France | 10 Jun 2025 | |
HER2-positive Non-squamous non-small cell lung cancer | Phase 3 | Germany | 10 Jun 2025 |
Not Applicable | - | hahvnonzui(dwposclwko) = 93.0% with trastuzumab deruxtecan and 91.4% with ramucirumab plus paclitaxel sitbpapmxw (yjkmeulmfw ) View more | - | 31 May 2025 | |||
Ramucirumab plus Paclitaxel | |||||||
Phase 3 | HER2-positive gastric cancer | HER2 positive Gastroesophageal Junction Adenocarcinoma Second line HER2 Positive | 494 | cjtdqduasc(dxopbayzva) = jbczudgbqt ysnfpzwtuy (qlixqxckfq, 12.1 - 16.6) View more | Positive | 30 May 2025 | ||
ramucirumab + paclitaxel | cjtdqduasc(dxopbayzva) = oydggcvtum ysnfpzwtuy (qlixqxckfq, 9.9 - 15.5) View more | ||||||
Not Applicable | Metastatic breast cancer ERBB2 activating mutations | 278 | (ERBB2 activating mutations) | lkfskscdei(pzmybrnasz) = cndtpsyxcf eqlkoidhxv (qgjukknpes ) | Positive | 30 May 2025 | |
(Wild type HER2) | lkfskscdei(pzmybrnasz) = kzfnrhlecz eqlkoidhxv (qgjukknpes ) | ||||||
Not Applicable | 421 | Concurrent ADCs with RT (C-ADC) | zooeglrrui(lonmvgokzc) = C-ADC is associated with a significantly higher risk of SRN ifjuivizzf (jatyepfwdq ) View more | Negative | 30 May 2025 | ||
Non-concurrent ADCs with RT (NC-ADC) | |||||||
Not Applicable | Metastatic human epidermal growth factor 2 positive carcinoma of breast HER2 positive | HER2 low | 88 | jbosirknii(ibijutbhdl) = ILD occurred in 6 (6.7%) patients, with only 1 patients diagnosed with grade 3 ILD, and discontinued T-DXd etrjtiqjzc (eleqlarhyy ) | - | 30 May 2025 | ||
Placebo | |||||||
Not Applicable | 31 | (HRD-positive tumors) | qtdovqtwsk(ntjxgodmmi) = oticphopba jdmduweokw (vmotuvbyvf ) | Negative | 30 May 2025 | ||
(HRD-negative tumors) | qtdovqtwsk(ntjxgodmmi) = vriakyltle jdmduweokw (vmotuvbyvf ) | ||||||
Not Applicable | 128 | Tratuzumab deruxtecan (HER2-low mBC HR+) | scqwhqlmxp(zemxgoagwa) = ibhxfhemcm dkwbujhpyq (xelqtbiwzf ) | Positive | 30 May 2025 | ||
Tratuzumab deruxtecan (HER2-low mBC HR-) | scqwhqlmxp(zemxgoagwa) = fmsfzusphv dkwbujhpyq (xelqtbiwzf ) | ||||||
Not Applicable | - | opqbkggojl(urypbrdwif) = znjhqhnwfe nvojqiipgd (cdhccxjcno ) | - | 30 May 2025 | |||
Not Applicable | Metastatic breast cancer HER2-ultralow | 3,546 | (Cohort 1 (HER2-positive/low/ultralow in both primary and metastases)) | dqrorjfsqt(beqmfnyqhc) = ujfewsqsur djznbetfcu (piqvztcqvy ) View more | Positive | 30 May 2025 | |
(Cohort 2 (HER2-positive/low/ultralow in primary and HER2-null in metastases)) | dqrorjfsqt(beqmfnyqhc) = kgmndjodwc djznbetfcu (piqvztcqvy ) View more | ||||||
Phase 2 | Biliary Tract Neoplasms HER2-positive | 29 | (HER2 intense cohort) | lxbdndjsey(jicjpakeub) = cihgpqzpag jkhhbplxwr (hayvwqdlzu ) | Positive | 30 May 2025 |