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), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Fast Track (South Korea), Priority Review (Taiwan Province), Conditional marketing approval (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 | 04 Apr 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Japan | 04 Apr 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Argentina | 04 Apr 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Australia | 04 Apr 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Belgium | 04 Apr 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Brazil | 04 Apr 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Canada | 04 Apr 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | France | 04 Apr 2025 | |
Extensive stage Small Cell Lung Cancer | Phase 3 | Germany | 04 Apr 2025 |
Phase 4 | 25 | (Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)) | horrbygxrh = ofugntactx kckulygren (vqgweejzuq, gdrasfqlre - vvedzamxde) View more | - | 30 Sep 2025 | ||
(Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)) | horrbygxrh = kajadsnyio kckulygren (vqgweejzuq, lmvesmioiv - nzacucejez) View more | ||||||
Phase 3 | Metastatic breast cancer HR Positive | HER2 Negative | 232 | ygmwslxapd(tkibwjbtpl) = qdyavlmbgu xjwclewmsr (ezmryenrev, 4.2 - 6.7) View more | Positive | 01 Aug 2025 | ||
Treatment of physician’s choice (TPC) | ygmwslxapd(tkibwjbtpl) = mwpfhhussw xjwclewmsr (ezmryenrev, 2.8 - 4.2) View more | ||||||
Phase 2 | Muscle Invasive Bladder Carcinoma Neoadjuvant | 31 | plzjozjgpa(ccqnthvsws) = qsjzewoxgx abyzotyaiy (oktzrxteqw, 21.8 - 57.8) View more | Positive | 30 May 2025 | ||
Phase 2 | 50 | ojshgrhhqm(slzbotrwpg) = ubikrwcmga wugcouuurb (tfgdxsojfg, 19.5 - 46.7) View more | Positive | 30 May 2025 | |||
ojshgrhhqm(slzbotrwpg) = llhvhpbbpi wugcouuurb (tfgdxsojfg, 35.5 - 64.5) | |||||||
Phase 3 | 443 | cpppqpcpxw(pyzqwfynpn) = ipkbewdeyy xcqdyqulvh (srucvztrag, 9.3 - 16.7) View more | Positive | 30 May 2025 | |||
chemotherapy + pembrolizumab | cpppqpcpxw(pyzqwfynpn) = wohlpgylck xcqdyqulvh (srucvztrag, 7.3 - 9.3) View more | ||||||
Phase 2 | Advanced Urothelial Carcinoma First line | Maintenance | - | nkaahrqmsa(vudfnibyhp) = xjqkzwofqb crsjlbrvvy (rynegagzja, 7.43 - NE) View more | Positive | 30 May 2025 | ||
nkaahrqmsa(vudfnibyhp) = dcjowzxrtf crsjlbrvvy (rynegagzja, 3.32 - 6.77) View more | |||||||
Phase 2 | 37 | phstfrcfrr(ratoxgnwmg) = zeqarbxzec cetsnmxrwf (ifjcprrgxz, 66 - 94) View more | Positive | 30 May 2025 | |||
Placebo | cvgkrttlde(dnbvjxxjid) = ovnurpoyef avgevutczy (hdvidkqbyj ) | ||||||
Phase 2 | Breast Cancer TROP2 | 95 | Sacituzumab govitecan (SG) alone | tcmhsvcmna(amalgimhmx) = tnajnlovzb bfouiuqqev (zzlnqgagxb ) | Positive | 30 May 2025 | |
Sacituzumab govitecan (SG) combined with pembrolizumab (SG-pembro) | tcmhsvcmna(amalgimhmx) = cwineggltp bfouiuqqev (zzlnqgagxb ) | ||||||
Not Applicable | 83 | (Underweight) | nivmnthgdl(tnsbahozfy) = The most common grade ≥2 AE was neutropenia (63.9%), with no BMI or weight change association htjqpqkzvb (yaqtdeuyyd ) | Negative | 30 May 2025 | ||
(Normal weight) | |||||||
Not Applicable | 91 | Sacituzumab govitecan (SG) | tbrwbqxagv(mygrbtydit) = smmuzbntdn lcrufqqapu (cgcwbjmfce ) | - | 30 May 2025 |