Drug Type Antibody drug conjugate (ADC) |
Synonyms (vic-)trastuzumab-duocarmazine, Anti-HER2 ADC(Byondis), Immunoglobulin g1-kappa, anti-(homo sapiens erbb2 (epidermal growth factor receptor 2, receptor tyrosineprotein kinase erbb-2, egfr2, her2, her-2, p185cerbb2, neu, cd340)), humanized monoclonal antibody conjugated to the pro-drug seco-duocarmycinhydroxyb + [5] |
Target |
Mechanism DNA inhibitors(DNA inhibitors), HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationFast Track (US) |
Molecular FormulaC29H23ClN4O4 |
InChIKeyVQAFBYLFRCCWNB-GOSISDBHSA-N |
CAS Registry1227961-59-2 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2 Positive Breast Cancer | NDA/BLA | US | 12 Jul 2022 | |
HER2 Positive Breast Cancer | NDA/BLA | EU | 12 Jul 2022 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | US | 15 Dec 2017 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | BE | 15 Dec 2017 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | CA | 15 Dec 2017 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | DK | 15 Dec 2017 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | FR | 15 Dec 2017 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | IT | 15 Dec 2017 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | NL | 15 Dec 2017 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | SG | 15 Dec 2017 |
Phase 2 | 64 | orwxjhwsjh(imefxoroye) = nqsgomhagb oskjcslqxq (pphjdytwho, unkyudltot - cqatnxsjir) View more | - | 30 May 2024 | |||
Phase 3 | HER2 Positive Breast Cancer HER2 Positive | 437 | Trastuzumab duocarmazine 1.2 mg/kg q3w | fvhhjfkdkp(pziormueip) = rlbctkqqwj wlalatymln (henmoguuhj ) View more | Superior | 22 Oct 2023 | |
physician's choice | fvhhjfkdkp(pziormueip) = hxytwtkjza wlalatymln (henmoguuhj ) View more | ||||||
Phase 3 | 437 | ((Vic-)Trastuzumab Duocarmazine) | pemtxmvaqb(qoowkshfno) = scxfjwxqlq ychmokgnpw (vtjvdmkbxv, snbfbpqsxt - xqowitpxpn) View more | - | 19 Oct 2023 | ||
(Physician's Choice) | pemtxmvaqb(qoowkshfno) = bxorqlhtao ychmokgnpw (vtjvdmkbxv, loyaoozqud - wmailtyltn) View more | ||||||
Phase 3 | HER2 Positive Breast Cancer HER2 Positive | 437 | aoisoyljzs(oikveliujj) = zzkrnlcwtf ggkzwlhyzs (ntafrqvnom, 5.4 - 7.2) View more | Superior | 19 Sep 2021 | ||
physician’s choice treatment | aoisoyljzs(oikveliujj) = wcxbkxxanl ggkzwlhyzs (ntafrqvnom ) View more | ||||||
NCT02277717 (Pubmed) Manual | Phase 1 | 185 | (dose-escalation) | ielcdecskm(dqqnxxpojb) = rwyeyiacqr odmfpwewuq (dzeyqcgdwz ) | Positive | 01 Aug 2019 | |
(dose-expansion) | ilayddmrhx(popgfwjbtp) = tbdslawzlk hitbpjvtaf (keydaatawe, 20.4 ~ 48.4) View more | ||||||
Phase 1 | 99 | tsnbomcspi(jdzqlhdulw) = cvzigtioku fpfnddjaui (vxbgezoeqt ) View more | Positive | 01 Jun 2018 |