Sacituzumab govitecan
Highest phase reached
Approved
Drug type
Antibody drug conjugate
First approval year
2020
- First approval year
- 2020
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody drug conjugate
- Drug name
- Sacituzumab govitecan
- trodelvy
- Trodelvy
- hrs7 sn38
- hrs7 sn38 antibody drug conjugate
- HRS7-SN38
- HRS7-SN38-ANTIBODY-DRUG-CONJUGATE
- hrs7sn38
- HRS7SN38
- immu 132
- IMMU-132
- immunoglobulin g1 anti human tumor associated calcium signal transducer 2 human mus musculus monoclonal hrs7 heavy chain disulfide with human mus musculus monoclonal hrs7 k chain dimer hexakis thioether with 4s 4 4 2 s 2 4 am inobutyl 2 2 2 26 4 4 3 merca pto 2 5 dioxo 1 pyrrolidinyl methyl cyclohexyl carbonyl amino methyl 1 h 1 2 3 triazol 1 yl 3 6 9 12 15 18 21 24 octaoxahexacos 1 yl amino 2 oxoethoxy acetyl amino 1 oxoethyl amino phenyl methoxy carbonyl oxy 4 11 diethyl 9 hydroxy 1 h pyrano 3 4 6 7 indolizino 1 2 b quinoline 3 14 4h 12h dione
- IMMUNOGLOBULIN G1, ANTI-(HUMAN TUMOR-ASSOCIATED CALCIUM SIGNAL TRANSDUCER 2) (HUMAN-MUS MUSCULUS MONOCLONAL HRS7 HEAVY CHAIN), DISULFIDE WITH HUMAN-MUS MUSCULUS MONOCLONAL HRS7 K-CHAIN, DIMER, HEXAKIS(THIOETHER) WITH ( 4S)-4-((((4-(((2 S)-2 -( 4-AM INOBUTYL )-2 -((2 -(2 -((26-(4-((((4-( (3-MERCA PTO-2,5-DIOXO-1-PYRROLIDINYL)METHYL)CYCLOHEXYL)CARBONYL)AMINO )METHYL)-1 H-1 ,2, 3-TRIAZOL-1-YL)-3,6,9, 12, 15,18,21 ,24-OCTAOXAHEXACOS-1-YL)AMINO)-2-OXOETHOXY)ACETYL)AMINO )-1-OXOETHYL)AMINO )PHENYL)METHOXY)CARBONYL)OXY)-4, 11-DIETHYL-9-HYDROXY-1 H-PYRANO(3',4':6, 7)INDOLIZINO(1 ,2-B)QUINOLINE-3, 14(4H, 12H)DIONE
- sacituzumab govitecan
- Sacituzumab govitecan
- Sacituzumab Govitecan
- Sacituzumab Govitecan (SG)
- sacituzumab govitecan [INN]
- SACITUZUMAB GOVITECAN [MI]
- SACITUZUMAB GOVITECAN [USAN]
- Sacituzumab govitecan [WHO-DD]
- Sacituzumab Govitecan for Injection
- sacituzumab govitecan hziy
- Sacituzumab govitecan hziy
- Sacituzumab govitecan hziy [WHO-DD]
- sacituzumab govitecan hziy who dd
- sacituzumab govitecan inn
- sacituzumab govitecan mi
And 9 more, listed on the interactive page.
- CAS registry numbers
- 1491917-83-9
- ChEMBL ID
- CHEMBL3545262
- RxNorm IDs (RxCUI)
- 2360232
- FDA ingredient codes (UNII)
- M9BYU8XDQ6
- L01FX06
- L01FX17
Sources for recorded values
- Applicant
- IMMUNOMEDICS INC
- Approval date
- 22 Apr 2020
- Application number
- BLA761115
- Status
- Authorised
- Status date
- 22 Nov 2021
- Authorisation date
- 22 Nov 2021
- Approved indications
- Triple-Negative Breast Cancer Trodelvy is indicated: as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy (see section 5.1). as monotherapy for the treatment of adult patients with unresectable or metastatic TNBC who have received two or more prior systemic therapies, including at least one of them for advanced disease (see section 5.1) HR-Positive, HER2-Negative Breast Cancer Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting.
- Product number
- EMEA/H/C/005182
- Authorisation holder
- Gilead Sciences Ireland UC
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Breast Neoplasms
- Triple Negative Breast Neoplasms
European medicines record
- Patents
- 0
- Designations
- 8
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- sacituzumab govitecan
- Type
- Antibody
- Drug name stem
- -mab; -mab; -tecan
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Tumor-associated calcium signal transducer 2 binding agent
- Action type
- BINDING_AGENT
- Target
- Tumor-associated calcium signal transducer 2
- Protein identifier
- P09758
- Action
- Binding
- Action type
- Binding
- Target
- tumor associated calcium signal transducer 2
- Gene symbol
- TACSTD2
- Protein identifier
- P09758
- Median affinity
- 9.54
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- DNA topoisomerase I inhibitor
- Action type
- Inhibitor
- Target
- DNA topoisomerase 1
- Protein identifier
- P11387
- Mechanism
- Tumor-associated calcium signal transducer 2 binding agent
- Action type
- BINDING AGENT
- Target
- Tumor-associated calcium signal transducer 2
- Mechanism
- DNA topoisomerase I inhibitor
- Action type
- Inhibitor
- Target
- DNA topoisomerase 1
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Mesothelioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001075
- Subject identifier
- D010051
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Urogenital Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003863
- Subject identifier
- D014565
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Triple Negative Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005537
- Subject identifier
- D064726
- Condition
- Brain Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005774
- Subject identifier
- D001927
- Condition
- Esophageal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005922
- Subject identifier
- D004938
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0008528
- Subject identifier
- D001749
- Condition
- Thymoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000576
- Subject identifier
- D013945
- Condition
- Thymoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000581
- Subject identifier
- D013945
- Condition
- Meningeal Carcinomatosis
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001012
- Subject identifier
- D055756
- Condition
- Endometrial Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001512
- Subject identifier
- D016889
- Condition
- Klatskin Tumor
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001959
- Subject identifier
- D018285
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0001187
- Subject identifier
- D001749
- Condition
- Thyroid Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002108
- Subject identifier
- D013964
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002974
- Subject identifier
- D002583
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004986
- Subject identifier
- D001749
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Prostatic Neoplasms, Castration-Resistant
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0008315
- Subject identifier
- D064129
And 2 more, listed on the interactive page.
- Condition identifier
- EFO_0000503
- Condition identifier
- EFO_0000519
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0001075
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003869
- Condition identifier
- EFO_0005537
- Condition identifier
- EFO_0005774
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005922
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008528
- Condition identifier
- EFO_1000576
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000581
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001012
- Highest recorded phase
- 1
- Condition identifier
- EFO_1001512
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001959
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002108
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002158
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002447
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002928
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002974
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003036
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004669
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004970
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004971
- Highest recorded phase
- 2
And 38 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- gastrointestinal toxicity
- Warning
- Black Box Warning
- Effect
- hematological toxicity
- Warning
- Black Box Warning
- Effect
- gastrointestinal toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- hematological toxicity
- Country
- United States
- Event
- anaemia
- Reports
- 16
- Reporting signal score
- 12.5656
- Event
- chemotherapy cytokine prophylaxis
- Reports
- 1
- Reporting signal score
- 9.00306
- Event
- chemotherapy side effect prophylaxis
- Reports
- 1
- Reporting signal score
- 8.30996
- Event
- colitis
- Reports
- 7
- Reporting signal score
- 11.2633
- Event
- cytopenia
- Reports
- 4
- Reporting signal score
- 8.63182
- Event
- dairy intolerance
- Reports
- 2
- Reporting signal score
- 12.8817
- Event
- diarrhoea
- Reports
- 26
- Reporting signal score
- 13.3821
- Event
- discontinued product administered
- Reports
- 2
- Reporting signal score
- 11.8762
- Event
- disease progression
- Reports
- 38
- Reporting signal score
- 89.7872
- Event
- disseminated varicella
- Reports
- 1
- Reporting signal score
- 6.70088
- Event
- enteritis
- Reports
- 4
- Reporting signal score
- 10.5366
- Event
- febrile neutropenia
- Reports
- 24
- Reporting signal score
- 50.7143
- Event
- hormone receptor positive her2 negative breast cancer
- Reports
- 1
- Reporting signal score
- 6.51865
- Event
- metastases to lung
- Reports
- 3
- Reporting signal score
- 6.3906
- Event
- neutropenia
- Reports
- 31
- Reporting signal score
- 50.9039
- Event
- neutropenic colitis
- Reports
- 8
- Reporting signal score
- 36.1584
- Event
- neutrophil count abnormal
- Reports
- 5
- Reporting signal score
- 17.9541
- Event
- neutrophil count decreased
- Reports
- 17
- Reporting signal score
- 38.2616
- Event
- sepsis
- Reports
- 7
- Reporting signal score
- 6.6673
- Event
- skin tightness
- Reports
- 4
- Reporting signal score
- 14.5347
- Event
- therapy change
- Reports
- 4
- Reporting signal score
- 10.4694
- Event
- triple negative breast cancer
- Reports
- 2
- Reporting signal score
- 10.3143
- Event
- ureteric obstruction
- Reports
- 2
- Reporting signal score
- 6.76248
- Event
- white blood cell count decreased
- Reports
- 14
- Reporting signal score
- 17.1636
- Event
- wound infection bacterial
- Reports
- 2
- Reporting signal score
- 9.89472
- NCT02161679
- NCT03971409
- NCT04454437
- NCT04958785
- NCT02574455
- NCT03424005
- NCT03901339
- NCT04039230
- NCT04230109
- NCT04434040
- NCT04448886
- NCT04468061
- NCT04639986
- NCT04927884
- NCT05008510
- NCT05113966
- NCT05143229
- NCT05332561
- NCT05552001
- NCT05675579
- NCT05840211
- NCT06081244
- NCT06100874
- NCT06102824
- NCT06236269
And 42 more, listed on the interactive page.
- Dose
- 10 mg/kg
- Route
- Intravenous
- How often
- Once weekly on Days 1 and 8 of 21-day cycles
- Administer as an intravenous infusion only
- Administer over 1-2 hours for subsequent infusions if tolerated
- Administer over 3 hours for the first infusion
- Do not administer as a push or bolus
- Do not mix with other medicinal products
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLQQSGSELKKPGASVKVSCKASGYTFTNYGMNWVKQAPGQGLKWMGWINTYTGEPTYTDDFKGRFAFSLDTSVSTAYLQISSLKADDTAVYFCARGGFGSSYWYFDVWGQGSLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQLTQSPSSLSASVGDRVSITCKASQDVSIAVAWYQQKPGKAPKLLIYSASYRYTGVPDRFSGSGSGTDFTLTISSLQPEDFAVYYCQQHYITPLTFGAGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 55135-132
Related records
Trials (139)
- A Multicenter, Prospective, Cohort Study of Trop-2 ADC Combination Therapy for Advanced Triple-negative Breast Cancer
- A Multicenter, Prospective, Phase II Study of TROP-2 ADC in Combination With Toripalimab for Resectable Locally Advanced Oral Squamous Cell Carcinoma
- A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors
- A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)
- A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors
- A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care
- A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)
- A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer
- A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
- A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
- A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
- A Study of Sacituzumab Govitecan (IMMU-132) in Endometrial Carcinoma
- A Study of Sacituzumab Govitecan (IMMU-132) in Patients With Recurrent or Persistent Cervical Cancer
- A Study of Sacituzumab Govitecan (IMMU-132) in Platinum-resistant Ovarian Cancer Patients
- A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
- A Study of Sacituzumab Govitecan in Combination With Cetuximab in People With Head and Neck Squamous Cell Cancer (HNSCC)
- A Study of Sacituzumab Govitecan in People With Mesothelioma
- A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC
- A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies
- A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
Approved for (5)
In development for (20)
- Brain disorder Phase 2
- Cervical cancer Phase 2
- Endometrial cancer Phase 3
- Endometrial carcinoma Phase 3
- Esophageal squamous cell carcinoma Phase 2
- Gastric adenocarcinoma Phase 1
- Glioblastoma Phase 2
- Hilar cholangiocarcinoma Phase 2
- Lung cancer Phase 2
- Mesothelioma Phase 2
- Non-small cell lung carcinoma Phase 3
- Ovarian carcinoma Phase 2
- Prostate cancer Phase 2
- Small cell lung carcinoma Phase 1
- Thymic carcinoma Phase 2
- Thymoma Phase 2
- Thyroid cancer Phase 2
- Urinary bladder cancer Phase 2
- Urinary bladder carcinoma Phase 2
- Urothelial carcinoma Phase 2