Last reviewed · How we verify
SACITUZUMAB GOVITECAN
SACITUZUMAB GOVITECAN is a drug. It is currently FDA-approved (first approved 2020).
Sacituzumab govitecan is an antibody-drug conjugate that targets the tumor-associated calcium signal transducer 2. It is being studied in clinical trials for various types of cancer, including cervical cancer, advanced solid tumors, urothelial cancer, and poorly differentiated neuroendocrine carcinomas.
At a glance
| Generic name | SACITUZUMAB GOVITECAN |
|---|---|
| Modality | Antibody drug conjugate |
| Phase | FDA-approved |
| First approval | 2020 |
Approved indications
Boxed warnings
- WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia [see Dosage and Administration (2.3) ] . Initiate anti-infective treatment in patient with febrile neutropenia without delay [see Warnings and Precautions (5.1) ]. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide [see Warnings and Precautions (5.2) ]. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses [see Dosage and Administration (2.3) ]. WARNING: NEUTROPENIA AND DIARRHEA See full prescribing information for complete boxed warning . TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm 3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. ( 2.3 , 5.1 ) TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. ( 2.3 , 5.2 )
Common side effects
- Neutropenia
- Nausea
- Diarrhea
- Fatigue
- Alopecia
- Anemia
- Vomiting
- Constipation
- Decreased appetite
- Rash
- Abdominal pain
- Respiratory infection
Key clinical trials
- Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
- Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer (PHASE3)
- Sacituzumab Govitecan, Preceding Radical Cystectomy, in Treating Patients With Muscle-invasive Bladder Cancer (PHASE2)
- 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 (PHASE1, PHASE2)
- Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer (PHASE1, PHASE2)
- Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer (PHASE2)
- Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial) (PHASE2)
- Study of Sacituzumab Tirumotecan Combined With Toripalimab for Resectable Stage II-IIIB NSCLC (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SACITUZUMAB GOVITECAN CI brief — competitive landscape report
- SACITUZUMAB GOVITECAN updates RSS · CI watch RSS
Frequently asked questions about SACITUZUMAB GOVITECAN
What is SACITUZUMAB GOVITECAN?
SACITUZUMAB GOVITECAN is a Antibody drug conjugate drug.
When was SACITUZUMAB GOVITECAN approved?
SACITUZUMAB GOVITECAN was first approved on 2020.
What development phase is SACITUZUMAB GOVITECAN in?
SACITUZUMAB GOVITECAN is FDA-approved (marketed).
What are the side effects of SACITUZUMAB GOVITECAN?
Common side effects of SACITUZUMAB GOVITECAN include Neutropenia, Nausea, Diarrhea, Fatigue, Alopecia, Anemia.
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing