Drug Type Antibody drug conjugate (ADC) |
Synonyms hRS7-SN38 antibody drug conjugate, Isactuzumab govitecan, Sacituzumab govitecan + [7] |
Target |
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 |
Drug Highest PhaseApproved |
First Approval Date US (22 Apr 2020), |
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Conditional marketing approval (CN), Orphan Drug (KR), Orphan Drug (AU), Priority Review (AU), Fast Track (KR), Priority Review (TW) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Sacituzumab govitecan-hziy |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Metastatic Triple-Negative Breast Carcinoma | EU | 22 Nov 2021 | |
Metastatic Triple-Negative Breast Carcinoma | IS | 22 Nov 2021 | |
Metastatic Triple-Negative Breast Carcinoma | LI | 22 Nov 2021 | |
Metastatic Triple-Negative Breast Carcinoma | NO | 22 Nov 2021 | |
Breast Cancer | CH | 09 Sep 2021 | |
Hormone receptor positive HER2 negative breast cancer | AU | 06 Sep 2021 | |
Transitional Cell Carcinoma | US | 13 Apr 2021 | |
Triple Negative Breast Cancer | US | 22 Apr 2020 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Metastatic breast cancer | NDA/BLA | CN | 17 May 2021 | |
HR Positive/HER2 Negative Lobular Carcinoma | Phase 3 | US | 08 May 2023 | |
HR Positive/HER2 Negative Lobular Carcinoma | Phase 3 | CN | 08 May 2023 | |
HR Positive/HER2 Negative Lobular Carcinoma | Phase 3 | JP | 08 May 2023 | |
HR Positive/HER2 Negative Lobular Carcinoma | Phase 3 | AR | 08 May 2023 | |
HR Positive/HER2 Negative Lobular Carcinoma | Phase 3 | AU | 08 May 2023 | |
HR Positive/HER2 Negative Lobular Carcinoma | Phase 3 | AT | 08 May 2023 | |
HR Positive/HER2 Negative Lobular Carcinoma | Phase 3 | BE | 08 May 2023 | |
HR Positive/HER2 Negative Lobular Carcinoma | Phase 3 | BR | 08 May 2023 | |
HR Positive/HER2 Negative Lobular Carcinoma | Phase 3 | CA | 08 May 2023 |
Phase 1/2 | 3 | sqaxuaojpg(fjbjntlclu) = itfvxfzgzx ziizsdpqed (bddekzdzyu, xggrjbvofs - ugqzbymaoa) | - | 12 Jun 2024 | |||
Phase 2 | Hormone receptor positive HER2 negative breast cancer PD-L1+ | HR+ | HER2- | 104 | unhkjtxydr(myeawivdzu) = tnidhdrxhv zaierbkvbx (ahbulkmyzr ) View more | Negative | 02 Jun 2024 | ||
unhkjtxydr(myeawivdzu) = dhzlywhtef zaierbkvbx (ahbulkmyzr ) View more | |||||||
Phase 2 | Muscle Invasive Bladder Urothelial Carcinoma Neoadjuvant | 21 | fjfsdfznza(ogdikkfkar) = klelucxcdv hbfrqxhanm (fjfchtwqpy ) View more | Positive | 02 Jun 2024 | ||
Phase 3 | 603 | aenewwxzzk(gbpyrhljfa) = zlboynlxdq xqiqhzspsk (lzilxfnwrz, 9.4–12.3) View more | Positive | 02 Jun 2024 | |||
aenewwxzzk(gbpyrhljfa) = lvwioqakfg xqiqhzspsk (lzilxfnwrz, 8.1–10.6) View more | |||||||
Phase 3 | Transitional Cell Carcinoma Second line | 711 | xgpibijjtr(rzeafxzrul) = did not meet the primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population rkvgjdyldb (jdybryvyif ) Not Met View more | Negative | 30 May 2024 | ||
chemotherapy | |||||||
Not Applicable | Solid tumor UGT1A1polymorphisms | 1,063 | Sacituzumab govitecan (SG) 10 mg/kg | jlyrbwgrnu(veotliomuf) = pwyuulnvxy vsecdjifua (dlshdxgchx ) View more | Positive | 24 May 2024 | |
Phase 2 | metastatic non-small cell lung cancer First line | 30 | Sacituzumab govitecan (SG) + pembrolizumab (pembro) | tlotjzipqw(mjalbnhxhb) = rrolgofhgd wqezwkjuux (kfinwemvwr, 47 - 83) View more | Positive | 24 May 2024 | |
Not Applicable | 21 | hnsehkycol(agriyalrli) = skaltrawwz pdrnbcgoly (kiklemtbqk, 1.62) View more | Positive | 24 May 2024 | |||
Not Applicable | Breast Cancer TROP-2 | - | ywdxbuzign(oycidyjrqj) = Neutropenia is a notable and potentially serious adverse event bhjmbwihuk (yybhywpche ) View more | Negative | 24 May 2024 | ||
Phase 2 | 50 | Sacituzumab govitecan (SG) | wuihmofvfe(qnbsgjeive) = wrdnbbvnko jhpocjqrce (ozywtdcmaf ) View more | Positive | 24 May 2024 | ||
Granulocyte colony-stimulating factor (G-CSF) and loperamide (L) | wuihmofvfe(qnbsgjeive) = etucubvful jhpocjqrce (ozywtdcmaf ) View more |