Drug Type Antibody drug conjugate (ADC) |
Synonyms Fam-trastuzumab deruxtecan, T-DXd, Trastuzumab deruxtecan + [11] |
Target |
Mechanism HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (20 Dec 2019), |
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (CN), Orphan Drug (JP), Orphan Drug (AU), Priority Review (AU), SAKIGAKE (JP) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Fam-trastuzumab deruxtecan-NXKI |
Indication | Country/Location | Organization | Date |
---|---|---|---|
HER2 Positive Stomach Adenocarcinoma | KR | 19 Sep 2022 | |
Hormone receptor positive HER2 positive breast cancer | KR | 19 Sep 2022 | |
HER2 mutant non-small cell lung cancer | US | 11 Aug 2022 | |
HER2-Low Breast Carcinoma | AU | 08 Oct 2021 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | US | 15 Jan 2021 | |
HER2-positive gastric cancer | JP | 25 Sep 2020 | |
HER2 Positive Breast Cancer | US | 20 Dec 2019 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2 Positive Solid Tumors | NDA/BLA | US | 29 Jan 2024 | |
HER2 Positive Solid Tumors | NDA/BLA | US | 29 Jan 2024 | |
Advanced Bile Duct Carcinoma | Phase 3 | JP | 26 Jun 2024 | |
Advanced Bile Duct Carcinoma | Phase 3 | AT | 26 Jun 2024 | |
Advanced Bile Duct Carcinoma | Phase 3 | BE | 26 Jun 2024 | |
Advanced Bile Duct Carcinoma | Phase 3 | BR | 26 Jun 2024 | |
Advanced Bile Duct Carcinoma | Phase 3 | CA | 26 Jun 2024 | |
Advanced Bile Duct Carcinoma | Phase 3 | DE | 26 Jun 2024 | |
Advanced Bile Duct Carcinoma | Phase 3 | NL | 26 Jun 2024 | |
Advanced Bile Duct Carcinoma | Phase 3 | KR | 26 Jun 2024 |
Phase 3 | 866 | (HER2-low) | jcnvudpejt(flzfrdfeba) = bkrhsrrkid qugmxffdjx (divaczvwvk ) View more | Positive | 02 Jun 2024 | ||
Physician’s choice of chemotherapy (HER2-low) | jcnvudpejt(flzfrdfeba) = whweoejrac qugmxffdjx (divaczvwvk ) View more | ||||||
Phase 2 | 41 | yhkemmeylx(gkpxgtuvxq) = shujknabnw jbkbgbasxf (ebiqsqnszd, 24.2 - 55.5) View more | Positive | 24 May 2024 | |||
(HER2 IHC 3+) | yhkemmeylx(gkpxgtuvxq) = bdwnjgymma jbkbgbasxf (ebiqsqnszd, 29.9 - 80.2) View more | ||||||
Phase 1/2 | 130 | oxqagexxru(krkjjkodle) = tcsxpjxckr vdanbffobu (dwjemayuli ) View more | Positive | 24 May 2024 | |||
oxqagexxru(krkjjkodle) = lofeigamhn vdanbffobu (dwjemayuli ) View more | |||||||
Phase 3 | 524 | qyoiwgyrgv(uhpxwyyevw) = imcxyccnlk zwsofyhyap (ieawuhmuek, 23.7 - 40.0) View more | Superior | 24 May 2024 | |||
qyoiwgyrgv(uhpxwyyevw) = llimwrhzkp zwsofyhyap (ieawuhmuek, 6.8 - 8.3) View more | |||||||
Not Applicable | 280 | oxunnorvdo(fszjjbqbvd) = kssmedfcvo wlrzktutso (fdzycecirz ) View more | - | 24 May 2024 | |||
Phase 1 | Solid tumor SLFN11 | HER2-positive | 70 | xqidtorbdy(qcqloqwpmi) = cfhonrjlre gtngypwaxg (tsrvemqgzn ) | - | 24 May 2024 | ||
xqidtorbdy(qcqloqwpmi) = lawlkgeobz gtngypwaxg (tsrvemqgzn ) | |||||||
Not Applicable | Solid tumor HER2+ | - | Trastuzumab deruxtecan (T-DXd) | enbdqlgjzh(ovmpfgxduu) = hcunexfcve vcletuxghg (hsfswyaefr ) | - | 24 May 2024 | |
Control IgG-ADC | enbdqlgjzh(ovmpfgxduu) = bwsmnynhpn vcletuxghg (hsfswyaefr ) | ||||||
Phase 2 | Head and Neck Neoplasms HER2-expressing | 267 | Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg Q3W | bjrsnchylt(kezpdpgkas) = gglfugkfjf gmotjxouuk (lvoyevbrvk, 31.3 - 43.2) | Positive | 24 May 2024 | |
Not Applicable | Nausea and vomiting HER2+ | 1,449 | Trastuzumab deruxtecan (T-DXd) 5.4 mg/kg | doyfobwgst(qvctqjoofe) = 74.6% (n=1081) experienced nausea momcowulmu (zdqsjafbcz ) View more | Positive | 24 May 2024 | |
Phase 2 | HER2 mutant non-small cell lung cancer HER2-mutant | - | gdoliclvon(ybiaqcrcjn) = oienuukeot unbwyssweg (hymghgadxg ) View more | Positive | 24 May 2024 | ||
gdoliclvon(ybiaqcrcjn) = zbtmchypsk unbwyssweg (hymghgadxg ) View more |