Drug Type Antibody drug conjugate (ADC) |
Synonyms Fam-trastuzumab deruxtecan, T-DXd, Trastuzumab deruxtecan + [13] |
Target |
Action antagonists, inhibitors |
Mechanism HER2 antagonists(Receptor protein-tyrosine 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 |
Drug Highest PhaseApproved |
First Approval Date United States (20 Dec 2019), |
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Australia), Priority Review (Australia), SAKIGAKE (Japan), Priority Review (United States), Breakthrough Therapy (United States), Orphan Drug (Japan) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Fam-trastuzumab deruxtecan-NXKI |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HR-positive/HER2-low Breast Carcinoma | United States | 28 Jan 2025 | |
HER2 Positive Stomach Adenocarcinoma | South Korea | 19 Sep 2022 | |
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-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 |
---|---|---|---|---|
HER2 Positive Solid Tumors | NDA/BLA | United States | 29 Jan 2024 | |
HER2 Positive Solid Tumors | NDA/BLA | United States | 29 Jan 2024 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | United States | 21 Mar 2025 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | China | 21 Mar 2025 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | Japan | 21 Mar 2025 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | Argentina | 21 Mar 2025 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | Australia | 21 Mar 2025 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | Austria | 21 Mar 2025 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | Belgium | 21 Mar 2025 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | Brazil | 21 Mar 2025 |
Phase 1 | metastatic non-small cell lung cancer | Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Locally Advanced Lung Non-Small Cell Carcinoma First line HER2 overexpression | 34 | zhtfkwpzrc(vxzcqhuxdq) = pueggiksvk rpfdrnukyn (xrlydvalza ) View more | Positive | 26 Mar 2025 | ||
Not Applicable | - | 48 | (High SAT density (HU)) | ubdrylljwm(ebpbfazjyg) = zqqlvkpofx jadphwtxww (movdeyypxb ) | Positive | 03 Mar 2025 | |
(High VAT density (HU)) | iykbhwwveo(wreqmcxjsn) = vbiwjzyuod ttlqehgwwb (liavxbxzvh ) | ||||||
Phase 1/2 | HER2-positive gastric cancer | HER2 positive Esophageal Carcinoma | HER2 positive Gastroesophageal Junction Adenocarcinoma First line HER2 Positive | 75 | gkrphwugwh(rtfnxtfbzp) = kapmtmzwog bydmrvanum (yeibwukpgq ) View more | Positive | 23 Jan 2025 | ||
gkrphwugwh(rtfnxtfbzp) = lrhsoomkfd bydmrvanum (yeibwukpgq ) View more | |||||||
Phase 1 | Non-Small Cell Lung Cancer HER2 Expression | ERBB2 Mutation (Activating) | 55 | (cohort 3 (HER2E; immunohistochemistry 1+, 2+, or 3+)) | cjghgponeh(jcfhjmnlum) = jhqjrjwgum iwzgfojoqh (gyvwzywugf, 32.2 - 75.6) View more | Positive | 12 Dec 2024 | |
(cohort 4 (HER2m)) | cjghgponeh(jcfhjmnlum) = edmmumqlsr iwzgfojoqh (gyvwzywugf, 48.2 - 82.0) View more | ||||||
Phase 2 | 95 | Trastuzumab deruxtecan 6.4 mg/kg | nbwofizhyx(rpxladusdb) = aofjiwmuvu licctzhjwe (zmojzylemm ) View more | Positive | 07 Dec 2024 | ||
Not Applicable | HER2-Low Breast Carcinoma HER2-low | IHC 1+ | IHC 2+ | 70 | ≥ 3 lines of chemotherapy | ojtzpidjod(aaemyufvpr) = grade 3-4 AEs were neutropenia, anemia, and leukopenia (each 7.1%) wmyyarxrqa (ekydcxnehh ) View more | Positive | 07 Dec 2024 | |
≤ 2 lines of chemotherapy | |||||||
Phase 2 | - | rzsmclbywo(xennaipfqu) = xbohccqxnb veulcagikz (nklofrqjfm, 5.6 - 8.0) View more | Positive | 07 Dec 2024 | |||
Phase 2 | 72 | asfrzsokvy = kqleidxmuu zyfqpkpaue (ofsincbuaz, wvjowbrmfh - cjnyqhhcjk) View more | - | 04 Dec 2024 | |||
Phase 1 | HER2-Low Breast Carcinoma HER2-low | 60 | zrncpiqtpu(smjeqtvwte) = zrdolbdwji yvpzkotnij (mpbmrvcvvt ) View more | Positive | 26 Nov 2024 | ||
zrncpiqtpu(smjeqtvwte) = gxqhusmfle yvpzkotnij (mpbmrvcvvt ) View more | |||||||
Phase 3 | 421 | Trastuzumab deruxtecan (T-DXd) (HER2 CN high) | pfhnhxywzx(ncjvrlqtlw) = vbphnvorki vxatrukxnd (xuvracrezy, 76.1 - 94.3) View more | Positive | 26 Nov 2024 | ||
Trastuzumab deruxtecan (T-DXd) (HER2 CN low) | pfhnhxywzx(ncjvrlqtlw) = bdljltysdm vxatrukxnd (xuvracrezy, 69.1 - 90.3) View more |