Unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) after ≥2 prior systemic therapies (including ≥1 for metastatic disease); Unresectable locally advanced or metastatic HR-positive/HER2-negative breast cancer after endocrine-based therapy and ≥2 additional systemic therapies; Locally advanced or metastatic urothelial cancer after prior platinum-based chemo and checkpoint inhibitor
10 mg/kg IV on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity
Infusion time: 1-3 hours for first infusion; may reduce to 1 hour if tolerated
Pre-medications: Antipyretics, H1 and H2 blockers, corticosteroids recommended. Atropine for early diarrhea.
For injection: 180 mg lyophilized powder in single-dose vial
Refer to the complete prescribing information for contraindications. Trodelvy prescribing should account for patient-specific factors including hypersensitivity to the active ingredient or any excipients.
Neutropenia (64%), diarrhea (63%), nausea (62%), fatigue (52%), alopecia (38%), anemia (34%), vomiting (33%), constipation (31%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.
Consult the full prescribing information for pregnancy-related considerations.
Refer to prescribing information for lactation guidance.
Pediatric safety and efficacy information is detailed in the full label.
Dose modifications for organ impairment are specified in the complete prescribing information.
Sacituzumab govitecan is an antibody-drug conjugate composed of a humanized anti-Trop-2 IgG1κ antibody conjugated to SN-38 (active metabolite of irinotecan) via a hydrolyzable CL2A linker. It targets Trop-2-expressing cancer cells, undergoes internalization, and releases SN-38 (a topoisomerase I inhibitor) to cause DNA damage and cell death.
Tmax: end of infusion. ADC half-life: ~16 hours. SN-38 (payload) half-life: ~18 hours. Clearance: 1.64 L/h. Vd: 15.1 L. SN-38 metabolized by UGT1A1 (Gilbert syndrome patients at higher risk for neutropenia). Excreted in urine (13%) and feces (55%).
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Trodelvy has FDA-approved indications across the following cancer types covered on PipelineEvidence: