TRODELVY (sacituzumab govitecan-hziy)
TRODELVY is indicated for the treatment of Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC); Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
How TRODELVY Works
Trodelvy functions as an antibody-drug conjugate that targets Trop-2-expressing cancer cells using a humanized antibody. Upon binding to the cell surface, the drug is internalized and releases SN-38, a topoisomerase I inhibitor, via hydrolysis of its linker. SN-38 then interacts with topoisomerase I to prevent the re-ligation of single-strand DNA breaks. This process results in DNA damage that leads to apoptosis and cell death.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-04-22
- Patent Cliff
- 2032
- Revenue
- $384M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TRODELVY Approval History
What TRODELVY Treats
2 indicationsTRODELVY is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)
- Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer
TRODELVY Boxed 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) ...
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 )
TRODELVY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TRODELVY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRODELVY treats. First-in-class if their pivotal trials read out positive.
Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06477419 | 24-081 | Ph 2 | recruiting | A Study of Sacituzumab Govitecan in People With Mesothelioma |
| NCT03964727 TROPiCS-03 results posted | IMMU-132-11 2019-000579-18, 2024-513611-28 | Ph 2 | active not recruiting | Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors |
| NCT05382299 ASCENT-03 | GS-US-592-6238 2021-005743-79, DOH-27082022-7958 | Ph 3 | active not recruiting | Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer |
| NCT04143711 | DF1001-001 | Ph 1, Ph 2 | completed | Study of DF1001 in Patients With Advanced Solid Tumors |
| NCT03547973 TROPHY U-01 | IMMU-132-06 2023-508302-24 | Ph 2 | recruiting | Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread |
| NCT04617522 | IMMU-132-15 2022-501508-82 | Ph 1 | recruiting | Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment |
| NCT04639986 | EVER-132-002 CTR20210096 | Ph 3 | active not recruiting | Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) |
| NCT04454437 | EVER-132-001 CTR20200914 | Ph 2 | active not recruiting | Study of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments |
| NCT06248515 | STUDY00007501 | Ph 2 | recruiting | A Phase II Trial of Sacituzumab Govitecan in Patients With Advanced Thymic Epithelial Tumors |
| NCT06486441 ASCENT-GYN-01 | GS-US-682-6769 2024-511957-23, GOG-3104 | Ph 3 | active not recruiting | Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26) |
| NCT05006794 | GS-US-467-5643 | Ph 1 | active not recruiting | Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Adults With Solid Malignancies |
| NCT05867251 | AVZO-021-1001 | Ph 1, Ph 2 | recruiting | Study of AVZO-021 in Patients With Advanced Solid Tumors |
| NCT05119907 | EVER-132-003 CTR20210912 | Ph 2 | active not recruiting | Study of Sacituzumab Govitecan in Patients With Solid Tumor |
| NCT04958785 ELEVATE TNBC results posted | GS-US-586-6144 2021-001074-27 | Ph 2 | terminated | Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer |
| NCT05840211 ASCENT-07 | GS-US-598-6168 2022-502593-17-00, jRCT2061230032 | Ph 3 | active not recruiting | Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy |
| NCT05382286 ASCENT-04 | GS-US-592-6173 2021-005742-14, KEYNOTE-D19 | Ph 3 | active not recruiting | Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer |
| NCT04527991 TROPiCS-04 | IMMU-132-13 2024-513870-23 | Ph 3 | completed | Study of Sacituzumab Govitecan Versus Physician's Choice of Treatment in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread |
| NCT05101096 ASCENT-J02 | GS-US-569-6172 jRCT2031210346 | Ph 1, Ph 2 | active not recruiting | Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors |
| NCT05113966 results posted | G1T28-213 | Ph 2 | terminated | Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer |
| NCT03901339 TROPiCS-02 results posted | IMMU-132-09 2018-004201-33 | Ph 3 | completed | Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer |
| NCT04927884 results posted | QUILT-3.058 | Ph 1, Ph 2 | terminated | A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies |
| NCT05008510 VERU-111 | V2011801 | Ph 2 | withdrawn | P2 Clinical Efficacy & Safety Study of V-111 Monotherapy & Sacituzumab Govitecan-hziy/V-111 Combo Therapy for mTNBC . |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRODELVY FDA Label Details
Indications & Usage
FDA Label (PDF)TRODELVY is indicated for the treatment of Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC); Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
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 pa...
Pro Intelligence Preview
Deep insights for TRODELVY
Revenue Insights
- • Q4-2025: $384M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • Generic/biosimilar risk
Trial Analysis
- • 22 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment