Last update 03 Jun 2024

Sacituzumab govitecan-hziy

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
hRS7-SN38 antibody drug conjugate, Isactuzumab govitecan, Sacituzumab govitecan
+ [7]
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
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Accelerated Approval (US), Orphan Drug (US), Priority Review (CN), Orphan Drug (KR), Orphan Drug (AU), Priority Review (AU), Fast Track (KR), Priority Review (TW)
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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
EU
22 Nov 2021
Metastatic Triple-Negative Breast Carcinoma
IS
22 Nov 2021
Metastatic Triple-Negative Breast Carcinoma
LI
22 Nov 2021
Metastatic Triple-Negative Breast Carcinoma
NO
22 Nov 2021
Breast Cancer
CH
09 Sep 2021
Hormone receptor positive HER2 negative breast cancer
AU
06 Sep 2021
Transitional Cell Carcinoma
US
13 Apr 2021
Triple Negative Breast Cancer
US
22 Apr 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Metastatic breast cancerNDA/BLA
CN
17 May 2021
HR Positive/HER2 Negative Lobular CarcinomaPhase 3
US
08 May 2023
HR Positive/HER2 Negative Lobular CarcinomaPhase 3
CN
08 May 2023
HR Positive/HER2 Negative Lobular CarcinomaPhase 3
JP
08 May 2023
HR Positive/HER2 Negative Lobular CarcinomaPhase 3
AR
08 May 2023
HR Positive/HER2 Negative Lobular CarcinomaPhase 3
AU
08 May 2023
HR Positive/HER2 Negative Lobular CarcinomaPhase 3
AT
08 May 2023
HR Positive/HER2 Negative Lobular CarcinomaPhase 3
BE
08 May 2023
HR Positive/HER2 Negative Lobular CarcinomaPhase 3
BR
08 May 2023
HR Positive/HER2 Negative Lobular CarcinomaPhase 3
CA
08 May 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
Sacituzumab govitecan (SG) + pembrolizumab (pembro)
saghmzkzyw(ozcnmcpaok) = rvtdxlopuu wxzyyhkdwp (wlzzrdysli, 47 - 83)
Positive
24 May 2024
Not Applicable
-
ofpcvdbikd(ftsghkfada) = Neutropenia is a notable and potentially serious adverse event izgpjrkmst (xugdezvtqx )
Negative
24 May 2024
Phase 1
41
Sacituzumab govitecan (SG) plus enfortumab vedotin (EV)
henenocbcu(svlgvlbxlw) = zwiasysjmp kvlamrupis (kflsvatjpv )
Positive
24 May 2024
Not Applicable
21
eoqylqkudj(ybtbbxxmps) = vbslpgeyyf jylllnggjo (fwqhjeohry, 1.62)
Positive
24 May 2024
Phase 3
-
sacituzumab govitecan
tmskgopczh(hbqwwsiefg): HR = 0.66 (95% CI, 0.55 - 0.80), P-Value = <0.001
Positive
16 May 2024
treatment of physician’s choice
Phase 3
528
(Underweight/Normal(< 25 kg/m2))
daavdwieox(pqnmbenbxa) = sfexsccvdc vitjrlktmc (mwjloueork, 2.9-5.6)
Positive
15 May 2024
Chemotherapy treatment of physician’s choice (TPC)
(Underweight/Normal(< 25 kg/m2))
daavdwieox(pqnmbenbxa) = kvtoqhltgu vitjrlktmc (mwjloueork, 1.5-2.8)
Phase 1/2
Triple Negative Breast Cancer
First line
HER2 Negative | PR Negative | ER Negative
39
dxymffemou(ydzkualjjz) = kbqwdplvkw ewjvipitcy (mtoqbqosdr )
Positive
15 May 2024
dxymffemou(ydzkualjjz) = ibpfazbdht ewjvipitcy (mtoqbqosdr )
Phase 2
63
topbvndvky(igyhlqnpox) = pdzecwkdfa zlzsbyyljp (tpwhzzxbuk )
Positive
22 Mar 2024
Not Applicable
23
jfkbmzyukv(euvjsfxyox) = kwyhstwfmu iyomsyvuod (gzsimbjmrh )
-
25 Jan 2024
Phase 2
41
Sacituzumab Govitecan + Pembrolizumab
yhkpygxocp(vymsvpwgwd) = mfnpafkieu bxwhxrxbcl (ytoeeobclp, 26.3 - 57.9)
Positive
23 Jan 2024
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