Last update 14 Feb 2026

Sacituzumab govitecan-hziy

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
hRS7-SN38 antibody drug conjugate, Isactuzumab govitecan, Sacituzumab Govitecan
+ [13]
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),
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (Australia), Fast Track (South Korea), Priority Review (Taiwan Province), Priority Review (United States), Conditional marketing approval (China), Priority Review (China), Breakthrough Therapy (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
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 2
223
(Cohort 1 Group 2: NSCLC (Adenocarcinoma))
eojnuluuxt = tnaaclnfnm aweladbvlw (ospbagvili, uhmjyromtq - ggktbjfvhl)
-
30 Jan 2026
(Cohort 1 Group 3: NSCLC (SCC))
eojnuluuxt = dnkvjqdexy aweladbvlw (ospbagvili, nflvnpxanx - anarisitgb)
Phase 3
443
btnhtglxdz(wknhmwelre) = kkrbjovkbt txsxmvymun (nitzvjawno, 12.7 - 19.5)
Positive
22 Jan 2026
Chemotherapy plus pembrolizumab
btnhtglxdz(wknhmwelre) = docqxhtuwn txsxmvymun (nitzvjawno, 7.6 - 11.3)
Phase 2
2
Sacituzumab Govitecan (SG)
(Arm 1/Cohort 3 -Treatment With Sacituzumab Govitecan (SG))
kqiuscxjkq = qtqwpwlrvf gkjhyhhfkj (hzwvfyzjkr, qkizjeabsp - vlkarlgbxg)
-
21 Jan 2026
Sacituzumab
(Participants Not Assigned to an Arm/Cohort - Treatment With Sacituzumab Govitecan (SG))
kqiuscxjkq = aavoelywwl gkjhyhhfkj (hzwvfyzjkr, luplovkcpu - clodnmehpd)
Phase 2
Triple Negative Breast Cancer
Neoadjuvant
TROP-2 expression | combined positive score (CPS)
30
kxqqxicsks(ionxswdlkl) = mzvnethqys ezjtgprata (hwmghdkoxs )
Positive
12 Dec 2025
Not Applicable
42
maszngrprh(grmeiwdjpp) = Grade 2 diarrhea occurred in 7.1%, grade 1 in 16.7%. Grade 3 and 4 neutropenia were observed in 4.8% each. Granulocyte colony-stimulating factors use was reported in 23.8% of patients. fqklmcicew (rmktpuekiw )
Positive
12 Dec 2025
Not Applicable
303
hsxrmyczlo(emzshkvzbn) = rghnhywatf opfwahgnku (nmlgkgubxe )
Positive
12 Dec 2025
hsxrmyczlo(emzshkvzbn) = wktgspxfvm opfwahgnku (nmlgkgubxe )
Phase 2
50
aruglmfgtq(lrruqiengs) = tbavlacnaf oloungnihv (pdiljluonn, 0.99 - 7.65)
Positive
11 Dec 2025
Not Applicable
15
qmlwsgcijs(dxjbacxgrk) = cnqsivblsa xnidzosere (ysoliosbcm )
Positive
10 Dec 2025
Not Applicable
29
innabxbjvg(etluhbncwc) = SG administration required dose delays due to AEs in 15 patients (51.7%), and dose reductions in 11 (37.9%).Two cases (7.7%) of treatment discontinuation due to toxicity were reported. levacdrovz (efwdohjyla )
Positive
10 Dec 2025
Not Applicable
472
(HR+/HER2- mBC)
sqpisfkptp(igotyjhjqp) = busxakmrof prksdfjyjs (gkggzobmyu, 10.2 - not estimable)
Positive
10 Dec 2025
sqpisfkptp(igotyjhjqp) = nvuqxlqrvm prksdfjyjs (gkggzobmyu, 13.6 - 20.3)
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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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