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항목
ADCCurated CoreFDAstaleApproved
sacituzumab govitecan-hziy (Trodelvy, IMMU-132, sacituzumab-govitecan-hziy)
Gilead / Immunomedics·TROP2
242 trials
Overview
Program
Trodelvy (sacituzumab govitecan-hziy)
Overview
Company
Gilead / Immunomedics
Overview
Modality
ADC
Overview
Target
TROP2
Overview
Indication
TNBC: regimen-specific first-line and previously treated indications; HR-positive/HER2-negative breast cancer after specified prior therapies. Consult current US label.
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Editorial scope · Curated Core
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
Very high DAR plus a deliberately unstable linker — extracellular SN-38 release gives bystander killing in TROP2-heterogeneous tumors.
Positioning
Known limitation
TROP2 downregulation, TOP1 mutation, and ABC-transporter payload efflux.
Positioning
Development positioning
Regimen-specific; includes 1L TNBC indications from June 2026
Technology
Payload
SN-38 (topoisomerase I inhibitor)
Technology
Linker
Hydrolyzable CL2A, DAR ~7.6
Technology
DAR
DAR 7.6
MoA
Mechanism
Anti-TROP2 antibody binds and internalizes; the hydrolyzable linker releases SN-38 both intracellularly and in the tumor microenvironment, inhibiting topoisomerase I and causing lethal DNA double-strand breaks.
MoA
Biomarker
TROP2 is broadly expressed in epithelial tumors; no companion diagnostic is required in the label.
Toxicology
Species
Cynomolgus monkey, Hamster
Toxicology
Major finding
Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common.
Toxicology
CRS
N/A
Clinical
Safety signal
Boxed warning for severe neutropenia and severe diarrhea. Nausea, alopecia, fatigue, and rare hypersensitivity are common.
Clinical
Selected reported efficacy
ORR 50%
Clinical
Reported ORR
50% vs 47% (chemotherapy)
Clinical
Reported PFS
9.7 months vs 6.9 months (chemotherapy)
Clinical
Reported OS
Immature in FDA approval analysis
Clinical
Result source
FDA approval report 2026-06-24 — ASCENT-03 (NCT05382299)
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT05382299
Preclinical
Animal (cat.)
Mouse