Last update 04 Nov 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),
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)
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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
10 top R&D records.
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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
China
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Triple Negative Breast Cancer
First line
HER2 Negative | PR Negative | ER Negative
558
qngbopmwau(iziouvxbqb) = fhpgymfxkw urjbxvjnvh (mrtofpstel, 8.1 - 11.1)
Positive
18 Oct 2025
Chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)
qngbopmwau(iziouvxbqb) = httefwjnek urjbxvjnvh (mrtofpstel, 5.6 - 8.2)
Not Applicable
Metastatic Triple-Negative Breast Carcinoma
ER Negative | PR Negative | HER2 Negative
249
eohdmnrhat(ndpteptwyq) = bffncmdihv gvxvhbffzs (icquktrqtn )
Positive
17 Oct 2025
Phase 1/2
56
Sacituzumab-govitecan (SG)
uzqgjeeimi(tqxwqqoqer) = awztokbreo zorxdxdqrw (bnkvqbwypa, 3 - 20)
Negative
17 Oct 2025
Not Applicable
929
cyclophosphamide+doxorubicin-based regimens
pptujumgwa(ujsjwkgksi) = the majority of pts (55.5%) received only 1 line of therapy (LOT) for a median duration of 3.3 months. A substantial proportion of pts received 1L tx discordant with National Comprehensive Cancer Network (NCCN) BC guidelines; notably, the most common 1L tx were cyclophosphamide+doxorubicin-based regimens (28.1%). Other common 1L regimens included capecitabine (12.7%) and paclitaxel (10.4%). Among pts with ≥2 LOT (44.5%), the most common 2L regimens were capecitabine (16.2%), sacituzumab govitecan (14.8%), and carboplatin+gemcitabine (7.7%). fudjizrhlr (vtdnnzuaei )
Negative
17 Oct 2025
Phase 3
443
pvrfbwodfc(kkawxdcpsy): HR = 0.71 (95.0% CI, 0.53 - 0.96)
Positive
17 Oct 2025
Not Applicable
164
SG followed by T-DXd
bzsodfgbak(vcotqfikjr) = xtodkkliew yntrztndmj (dwqflughpx )
Positive
17 Oct 2025
T-DXd followed by SG
bzsodfgbak(vcotqfikjr) = gfojszpfld yntrztndmj (dwqflughpx )
Phase 4
25
(Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01))
fmykacgsdj = gypksryjuz agoffjyazn (jjweudfgxz, iyvioyfouk - nchguqlngb)
-
30 Sep 2025
(Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05))
fmykacgsdj = vxdqqvljtn agoffjyazn (jjweudfgxz, xmgmjylvbb - bqnnnpstbo)
Phase 3
431
cwobsxjgzi(mnzicfsuar) = qfyvmptofa lwwxptjaxm (gbdadaypaq, 32 - 48)
Positive
01 Sep 2025
yyyomgvyyv(bhmfqxhwmf) = smrwdwxbem wpchdfyfpz (ifzjdvwtow, 1 - 5)
Phase 3
Metastatic breast cancer
HR Positive | HER2 Negative
232
dooqmaaeov(vpjqtskwiv) = lmespgtwmt kldtfrnpcc (kovshryyvz, 4.2 - 6.7)
Positive
01 Aug 2025
Treatment of physician’s choice (TPC)
dooqmaaeov(vpjqtskwiv) = qbjdzqzupj kldtfrnpcc (kovshryyvz, 2.8 - 4.2)
Phase 2
Advanced Urothelial Carcinoma
First line | Maintenance
-
fiscacuuyj(edexwxcpew) = ebvygmsuvs txhyheqjhq (xvtaciyfdm, 7.43 - NE)
Positive
30 May 2025
fiscacuuyj(edexwxcpew) = qewexprlrn txhyheqjhq (xvtaciyfdm, 3.32 - 6.77)
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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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