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Trodelvy (sacituzumab-govitecan)
Trodelvy works by binding to the TACI receptor on cancer cells, triggering a cascade of events that ultimately leads to cell death.
Trodelvy (sacituzumab-govitecan) is a cancer treatment developed by Immunomedics Inc. It targets the Tumor-associated calcium signal transducer 2 (TACI) on cancer cells, leading to cell death. Trodelvy is approved for the treatment of triple-negative breast cancer. It is a patented product with a proprietary modality as a small molecule. Key safety considerations include neutropenia and diarrhea.
At a glance
| Generic name | sacituzumab-govitecan |
|---|---|
| Sponsor | Immunomedics Inc |
| Target | Tumor-associated calcium signal transducer 2 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2020 |
| Annual revenue | 800 |
Mechanism of action
Sacituzumab govitecan-hziy is Trop-2-directed antibody-drug conjugate. Sacituzumab is humanized antibody that recognizes Trop-2. The small molecule, SN-38, is topoisomerase inhibitor, which is covalently attached to the antibody by linker. Pharmacology data suggest that sacituzumab govitecan-hziy binds to Trop-2-expressing cancer cells and is internalized with the subsequent release of SN-38 via hydrolysis of the linker. SN-38 interacts with topoisomerase and prevents re-ligation of topoisomerase I-induced single strand breaks. The resulting DNA damage leads to apoptosis and cell death. Sacituzumab govitecan-hziy decreased tumor growth in mouse xenograft models of triple-negative breast cancer.
Approved indications
- Triple negative breast neoplasms
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
- decreased leukocyte count
- decreased neutrophil count
- decreased hemoglobin
- diarrhea
- nausea
- decreased lymphocyte count
- fatigue
- alopecia
- constipation
- increased glucose
- decreased albumin
- vomiting
Key clinical trials
- Study of Sacituzumab Govitecan-hziy (IMMU-132) in Adults With Epithelial Cancer (PHASE1,PHASE2)
- Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) (PHASE3)
- 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)
- Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer (PHASE3)
- 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)
- Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
- A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan Versus Standard of Care in the Treatment of Advanced Urothelial Cancer (PHASE3)
- Sacituzumab Govitecan in Recurrent Glioblastoma (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 |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Trodelvy CI brief — competitive landscape report
- Trodelvy updates RSS · CI watch RSS
- Immunomedics Inc portfolio CI