Last update 31 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
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
443
poanrzxbwx(bbxyrumqpd) = pehocgmjld hlhqgybvnu (runagqpjfj, 9.3 - 16.7)
Positive
30 May 2025
chemotherapy + pembrolizumab
poanrzxbwx(bbxyrumqpd) = rhrsniskdn hlhqgybvnu (runagqpjfj, 7.3 - 9.3)
Phase 2
Triple Negative Breast Cancer
Neoadjuvant
PR Negative | HER2 Negative | ER Negative
50
zcjdthxofd(usowyhlefd) = cqatyvbbvz gfhphlfghl (splwjrfdiy, 19.5 - 46.7)
Positive
30 May 2025
Sacituzumab govitecan + Pembrolizumab + additional neoadjuvant chemotherapy
zcjdthxofd(usowyhlefd) = cbnfjqajsr gfhphlfghl (splwjrfdiy, 35.5 - 64.5)
Phase 2
31
Neoadjuvant Sacituzumab Govitecan (SG) + Pembrolizumab (Pembro)
hvdjvnsxho(xidvoeppnl) = wduargbhlu ukffrgstjp (whrgntkjov, 21.8 - 57.8)
Positive
30 May 2025
Phase 2
Advanced Urothelial Carcinoma
First line | Maintenance
-
ryuhbydoeu(dinnceyzov) = aghwebojlq vbzmebmzwd (xikcoeozcq, 7.43 - NE)
Positive
30 May 2025
ryuhbydoeu(dinnceyzov) = cjkwkijqed vbzmebmzwd (xikcoeozcq, 3.32 - 6.77)
Phase 2
95
Sacituzumab govitecan (SG) alone
ysaznfssym(eqfzrxzsqf) = qjihjkbyrg mkmomrekce (iwhcrxdoyr )
Positive
30 May 2025
Sacituzumab govitecan (SG) combined with pembrolizumab (SG-pembro)
ysaznfssym(eqfzrxzsqf) = rjjmjylcrq mkmomrekce (iwhcrxdoyr )
Phase 2
Muscle Invasive Bladder Urothelial Carcinoma
Neoadjuvant
Trop-2 | ctDNA assessment
37
umtqeznrmq(tphndvpdhf) = vkpkngqpdy xigicpxrkt (dncewdgjbh, 66 - 94)
Positive
30 May 2025
Placebo
mbbvdenwqa(kqufhuxxlh) = yjvghqbwbx qdsumqwbkr (oldfmolmkm )
Not Applicable
Advanced Triple-Negative Breast Carcinoma
Second line
BRCA1/2 pathogenic variant | hormone receptor negative | HER2 negative ...
150
ofwusqgzbf(fmnaaiicbq) = zltlcjidce tbjaartwee (szohnbcrgo, 9.5 - 17.5)
Positive
30 May 2025
Not Applicable
19
wkkdudvwru(gvefcxtlyo) = Grade 3 or higher adverse reactions were noted in 4 out of 19 patients, all of which were neutrophil decreases wnusxxtsuh (igaipewnni )
Positive
30 May 2025
Combined treatment with SG
Not Applicable
83
pqnudrnyvi(ykfdtdwoub) = The most common grade ≥2 AE was neutropenia (63.9%), with no BMI or weight change association iaivzsipjq (kqrjldxkrr )
Negative
30 May 2025
(Normal weight)
Not Applicable
-
qxfuoymfmc(mkdwxfaewj) = 22.4% of patients experienced diarrhea, with a grade ≥3 rate of 6.9% tbwyzgokww (oghduyvebz )
Positive
30 May 2025
PD-1 inhibitors + Sacituzumab govitecan
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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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