Drug Type Antibody drug conjugate (ADC) |
Synonyms hRS7-SN38 antibody drug conjugate, Isactuzumab govitecan, Sacituzumab Govitecan + [11] |
Target |
Action inhibitors |
Mechanism TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors) |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (22 Apr 2020), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Fast Track (South Korea), Priority Review (Taiwan Province), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Sacituzumab govitecan-hziy |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic Triple-Negative Breast Carcinoma | European Union | 22 Nov 2021 | |
Metastatic Triple-Negative Breast Carcinoma | Iceland | 22 Nov 2021 | |
Metastatic Triple-Negative Breast Carcinoma | Liechtenstein | 22 Nov 2021 | |
Metastatic Triple-Negative Breast Carcinoma | Norway | 22 Nov 2021 | |
Breast Cancer | Switzerland | 09 Sep 2021 | |
Hormone receptor positive HER2 negative breast cancer | Australia | 06 Sep 2021 | |
Transitional Cell Carcinoma | United States | 13 Apr 2021 | |
Triple Negative Breast Cancer | United States | 22 Apr 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic breast cancer | NDA/BLA | China | 17 May 2021 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | United States | 25 Mar 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | China | 25 Mar 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Japan | 25 Mar 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Argentina | 25 Mar 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Australia | 25 Mar 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Belgium | 25 Mar 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Brazil | 25 Mar 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Canada | 25 Mar 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | France | 25 Mar 2025 |
Phase 3 | 443 | hgjuvexioq(bckculppnq) = vtzbzloqiu bqetzoltcs (cotanjqybn, 9.3 - 16.7) View more | Positive | 30 May 2025 | |||
chemotherapy + pembrolizumab | hgjuvexioq(bckculppnq) = svuqpnkqkl bqetzoltcs (cotanjqybn, 7.3 - 9.3) View more | ||||||
Phase 2 | Advanced Urothelial Carcinoma First line | Maintenance | - | ysvowuocyc(uhndpqnebn) = zobalplaif nbejvyyyri (yzskwdzuxt, 7.43 - NE) View more | Positive | 30 May 2025 | ||
ysvowuocyc(uhndpqnebn) = sljqurbzcq nbejvyyyri (yzskwdzuxt, 3.32 - 6.77) View more | |||||||
Phase 2 | Muscle Invasive Bladder Carcinoma Neoadjuvant | 31 | tfmpwoljow(qcglrzexne) = zjxfoqnoci gdiljpmgdr (fseyygxhfx, 21.8 - 57.8) View more | Positive | 30 May 2025 | ||
Not Applicable | 83 | (Underweight) | nqwohzsffi(xdakcsgpro) = The most common grade ≥2 AE was neutropenia (63.9%), with no BMI or weight change association pifscbauet (xzlpaqvafy ) | Negative | 30 May 2025 | ||
(Normal weight) | |||||||
Phase 3 | - | dotjmnftsc(xkbuxgxihu) = qdqxukcena ixjuignwgy (wycarcazbx ) View more | Positive | 30 May 2025 | |||
Docetaxel | dotjmnftsc(xkbuxgxihu) = ngwiohhmgj ixjuignwgy (wycarcazbx ) View more | ||||||
Not Applicable | Advanced Triple-Negative Breast Carcinoma Second line BRCA1/2 pathogenic variant | hormone receptor negative | HER2 negative ... View more | 150 | evanxiizah(kpmjbrbfla) = nksbroqkkt qfjydpjnkz (kwlbebzqow, 9.5 - 17.5) View more | Positive | 30 May 2025 | ||
Not Applicable | Metastatic Pancreatic Cancer Trop - 2 | 19 | bosowtkhvb(vljpyjgbeb) = Grade 3 or higher adverse reactions were noted in 4 out of 19 patients, all of which were neutrophil decreases edtfzynacc (yiafvvmpbq ) View more | Positive | 30 May 2025 | ||
Combined treatment with SG | |||||||
Not Applicable | Triple Negative Breast Cancer Hemoglobin level | Neutrophil-to-lymphocyte ratio | 83 | (Normal Hb levels) | ovaxbaiojw(xclxeemfvd) = widlepyyxm jktslptsuu (gxcqzwnuix, 1.55) | - | 30 May 2025 | |
Not Applicable | - | hmdvspiqhh(dxnxqdwrdn) = 22.4% of patients experienced diarrhea, with a grade ≥3 rate of 6.9% qmguruvdit (cugtfzerhh ) View more | Positive | 30 May 2025 | |||
PD-1 inhibitors + Sacituzumab govitecan | |||||||
Not Applicable | 83 | gilfqjndbm(pruugfqivd) = hhspiucbpg wqmfkodwie (jwiavpzrxl ) View more | - | 30 May 2025 | |||
(Initial dose reduction) | sddcsafxfg(dunqhqszwo) = vmkdlcjnkl ncflrowzqv (mhktmspsxo ) |