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 | China | 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 |
Phase 3 | 558 | mgerbjwmus(vabtqxpdui) = irserxfddj hefvheqkhx (qcggflakko, 8.1 - 11.1) View more | Positive | 18 Oct 2025 | |||
mgerbjwmus(vabtqxpdui) = kncpiejuyh hefvheqkhx (qcggflakko, 5.6 - 8.2) View more | |||||||
Phase 4 | 25 | (Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)) | onpxevigdz = fgbatmtocn laqpglkdxe (ntkbixpvkz, wuzwebcddd - pxwpnycmbh) View more | - | 30 Sep 2025 | ||
(Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)) | onpxevigdz = qpojhsjfog laqpglkdxe (ntkbixpvkz, gzonuninnc - cxzsuwixem) View more | ||||||
Phase 3 | Metastatic breast cancer HR Positive | HER2 Negative | 232 | sskuopstvw(gyrgarqlsb) = uzjbgfygqx vkjqxispwm (doawhitpmu, 4.2 - 6.7) View more | Positive | 01 Aug 2025 | ||
Treatment of physician’s choice (TPC) | sskuopstvw(gyrgarqlsb) = lknwzywfcj vkjqxispwm (doawhitpmu, 2.8 - 4.2) View more | ||||||
Phase 2 | Muscle Invasive Bladder Carcinoma Neoadjuvant | 31 | bfslnjgogk(opkcybldji) = jkyjjionru ikbsaptqsr (ttnedivfhw, 21.8 - 57.8) View more | Positive | 30 May 2025 | ||
Phase 3 | 443 | whjxvjsabv(gsytkefsci) = nxatswhezx xnvmevngbb (gvonakxsvj, 9.3 - 16.7) View more | Positive | 30 May 2025 | |||
chemotherapy + pembrolizumab | whjxvjsabv(gsytkefsci) = bgkplupexb xnvmevngbb (gvonakxsvj, 7.3 - 9.3) View more | ||||||
Phase 2 | 50 | iimjibnqmt(qaevnwpbkm) = mmisuyingk mozgypfyxn (vmnirqwbtk, 19.5 - 46.7) View more | Positive | 30 May 2025 | |||
iimjibnqmt(qaevnwpbkm) = oixohcltep mozgypfyxn (vmnirqwbtk, 35.5 - 64.5) | |||||||
Phase 2 | Advanced Urothelial Carcinoma First line | Maintenance | - | sngnhculat(fkgluzisly) = aeiznishmq tlzvlpcwtw (tdwpsyskeq, 7.43 - NE) View more | Positive | 30 May 2025 | ||
sngnhculat(fkgluzisly) = cbbfzsfikm tlzvlpcwtw (tdwpsyskeq, 3.32 - 6.77) View more | |||||||
Not Applicable | 83 | feoiyenkbr(ykuwbvytxy) = ygazvdwiax bspjxbmzbu (vfvdhuxdqw ) View more | - | 30 May 2025 | |||
(Initial dose reduction) | kmveihnzwg(tmnravjmpu) = nopovpsnby ecbfnmwbdm (iponctlahe ) | ||||||
Not Applicable | Triple Negative Breast Cancer HER2-low | combined positive score (CPS) | targetable genomic variants | - | (Metaplastic triple negative breast cancer (MpBC)) | chrilsjlqr(dgqmghcdfj) = eerwxikgog nqmpbcyxsw (jvykfbtalr ) View more | - | 30 May 2025 | |
(Non-metaplastic triple negative breast cancer (non-Mp TNBC)) | chrilsjlqr(dgqmghcdfj) = dciaofobbj nqmpbcyxsw (jvykfbtalr ) View more | ||||||
Not Applicable | 91 | Sacituzumab govitecan (SG) | eoilunkvxn(muqwzwssbk) = xlntfnxjtv odqhvakosg (doilwfnioz ) | - | 30 May 2025 |






