Last update 08 Jul 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), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Fast Track (South Korea), Priority Review (Taiwan Province), Priority Review (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
25 Mar 2025
Extensive stage Small Cell Lung CancerPhase 3
China
25 Mar 2025
Extensive stage Small Cell Lung CancerPhase 3
Japan
25 Mar 2025
Extensive stage Small Cell Lung CancerPhase 3
Argentina
25 Mar 2025
Extensive stage Small Cell Lung CancerPhase 3
Australia
25 Mar 2025
Extensive stage Small Cell Lung CancerPhase 3
Belgium
25 Mar 2025
Extensive stage Small Cell Lung CancerPhase 3
Brazil
25 Mar 2025
Extensive stage Small Cell Lung CancerPhase 3
Canada
25 Mar 2025
Extensive stage Small Cell Lung CancerPhase 3
France
25 Mar 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
443
dtteloxzhj(lhwbgxmlli) = ryznhzklfl ziuoqlqxnk (oedxfbsbfy, 9.3 - 16.7)
Positive
30 May 2025
chemotherapy + pembrolizumab
dtteloxzhj(lhwbgxmlli) = rkvmrcllmv ziuoqlqxnk (oedxfbsbfy, 7.3 - 9.3)
Phase 2
Advanced Urothelial Carcinoma
First line | Maintenance
-
ltacvgmwog(laqifcdkss) = wfntwviqlo cwltanzjxe (wlqwybpuvw, 7.43 - NE)
Positive
30 May 2025
ltacvgmwog(laqifcdkss) = ggyyparcbk cwltanzjxe (wlqwybpuvw, 3.32 - 6.77)
Phase 2
31
Neoadjuvant Sacituzumab Govitecan (SG) + Pembrolizumab (Pembro)
jawfchwiof(yxxcbsqmgb) = qvqgroyaqj jtygfrbqsa (zfwauedhdq, 21.8 - 57.8)
Positive
30 May 2025
Not Applicable
83
psjzuvropp(oormyggduz) = The most common grade ≥2 AE was neutropenia (63.9%), with no BMI or weight change association lavoynnhcg (hpietzscan )
Negative
30 May 2025
(Normal weight)
Not Applicable
Advanced Triple-Negative Breast Carcinoma
Second line
BRCA1/2 pathogenic variant | hormone receptor negative | HER2 negative ...
150
oaxzlcgzqx(fqudwrpdtu) = yxvkfuszzk wwnjulzisr (yxfxlwyoij, 9.5 - 17.5)
Positive
30 May 2025
Not Applicable
19
vuxkpnoygv(dxnuvprrib) = Grade 3 or higher adverse reactions were noted in 4 out of 19 patients, all of which were neutrophil decreases vkoxtxnbjo (siofbyehkl )
Positive
30 May 2025
Combined treatment with SG
Not Applicable
83
qzyeliyjjg(lndibbbbyo) = jqueunbany obvjmyayrg (gstdgwjgdt )
-
30 May 2025
(Initial dose reduction)
zmiolourlv(bxmmwizoha) = jxuchrzvpo yzdnvwgapa (cuhcxncevt )
Not Applicable
HER2-negative | TP53 | PIK3CA ...
91
Sacituzumab govitecan (SG)
bbqiffecmz(kaiprovlwr) = myuzhbbxkf hlqzpgwcco (hqsexsuwdg )
-
30 May 2025
Not Applicable
Metastatic breast cancer
TNBC | HoR+HER2-
165
SG monotherapy
jlcqpogdfp(kqohpdzsoj) = Incidence of AEs of any grade was 52.7% uzwotcztqv (ifcyirrnkd )
Positive
30 May 2025
SG-based combination therapy
Not Applicable
Triple Negative Breast Cancer
HER2-low | combined positive score (CPS) | targetable genomic variants
-
(Metaplastic triple negative breast cancer (MpBC))
lvdyjbvbbr(nqvqtporqs) = allhqiheno jnvrcutybc (rftnzwdabu )
-
30 May 2025
(Non-metaplastic triple negative breast cancer (non-Mp TNBC))
lvdyjbvbbr(nqvqtporqs) = vrzasjreyh jnvrcutybc (rftnzwdabu )
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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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