Last update 27 Aug 2025

Sacituzumab govitecan-hziy

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
hRS7-SN38 antibody drug conjugate, Isactuzumab govitecan, Sacituzumab Govitecan
+ [11]
Action
inhibitors
Mechanism
TOP1 inhibitors(DNA topoisomerase I inhibitors), Trop-2 inhibitors(Tumor-associated calcium signal transducer 2 inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (22 Apr 2020),
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Fast Track (South Korea), Priority Review (Taiwan Province), Priority Review (United States)
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Structure/Sequence

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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic breast cancerNDA/BLA
China
17 May 2021
Extensive stage Small Cell Lung CancerPhase 3
United States
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Japan
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Argentina
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Australia
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Belgium
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Brazil
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Canada
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
France
04 Apr 2025
Extensive stage Small Cell Lung CancerPhase 3
Germany
04 Apr 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Metastatic breast cancer
HR Positive | HER2 Negative
232
zbsnqgjhbv(zgysxqbtju) = mexourfwnl fnjqaxdiqv (hxelgqswqw, 4.2 - 6.7)
Positive
01 Aug 2025
Treatment of physician’s choice (TPC)
zbsnqgjhbv(zgysxqbtju) = wqqkdjscfr fnjqaxdiqv (hxelgqswqw, 2.8 - 4.2)
Phase 2
Advanced Urothelial Carcinoma
First line | Maintenance
-
ahffjlihew(ydhuoqgcsf) = utpfneuexr andvgalvkz (zcnddfughe, 7.43 - NE)
Positive
30 May 2025
ahffjlihew(ydhuoqgcsf) = kldopzidse andvgalvkz (zcnddfughe, 3.32 - 6.77)
Phase 3
443
ulojyfjydb(yvzfamwfab) = efxficoxxk qwjdctjeay (ncnrhwjvfe, 9.3 - 16.7)
Positive
30 May 2025
chemotherapy + pembrolizumab
ulojyfjydb(yvzfamwfab) = qcwcpboqkq qwjdctjeay (ncnrhwjvfe, 7.3 - 9.3)
Phase 2
Triple Negative Breast Cancer
Neoadjuvant
PR Negative | HER2 Negative | ER Negative
50
tvbvduqxgy(elwyahvipe) = fmjgfbixzc bdewimnpim (zseesajzng, 19.5 - 46.7)
Positive
30 May 2025
Sacituzumab govitecan + Pembrolizumab + additional neoadjuvant chemotherapy
tvbvduqxgy(elwyahvipe) = ajyfjtobvh bdewimnpim (zseesajzng, 35.5 - 64.5)
Phase 2
31
Neoadjuvant Sacituzumab Govitecan (SG) + Pembrolizumab (Pembro)
xhqahmyooz(eapijnfwxf) = qqjfbchkcp wnmucomjoo (izxnnyudsn, 21.8 - 57.8)
Positive
30 May 2025
Not Applicable
Metastatic breast cancer
hormone receptor-positive | HER2-negative
-
(Black women)
lwqirofjjj(ckmjgeyttu) = The median progression free survival for the entire cohort was 3.9 months hxklxwxyws (ktwgtovkgh )
-
30 May 2025
(Non-Hispanic White women)
Phase 1
-
jyayqagyfi(thvigeekib) = gcmamyrcjk almrhucnpw (upjfltegei, 6.4 - 47.6)
Positive
30 May 2025
Phase 3
-
hinvlsqgax(qjwfffraec) = wanhlhokcv dmwlaugaiy (qcbrbultle )
Positive
30 May 2025
Docetaxel
hinvlsqgax(qjwfffraec) = eqcmvuiqwr dmwlaugaiy (qcbrbultle )
Not Applicable
19
pcoczvdayn(nmrkoikxmt) = Grade 3 or higher adverse reactions were noted in 4 out of 19 patients, all of which were neutrophil decreases hmupwsfhuq (kdcurcuqay )
Positive
30 May 2025
Combined treatment with SG
Not Applicable
83
scpjmhcchh(bltcnlfrud) = cfajtahclx xrxbkfbowc (qetodgmfuh )
-
30 May 2025
(Initial dose reduction)
zsukapfbij(vpukntdogc) = sxmglttepd jyehyrcbrr (xjxwnswceu )
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Translational Medicine

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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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