National Comprehensive
Cancer Network® (NCCN®)
The only Trop-2–directed ADC designated as an NCCN Category 1 preferred regimen for both pretreated HR+/HER2- mBC and mTNBC (HR-/HER2-).1 See below for NCCN recommendations
In the Phase 3 TROPiCS-02 study (pretreated HR+/HER2- mBC), TRODELVY demonstrated 3.2 more months of overall survival than single-agent chemotherapy (14.4 vs 11.2 month mOS [P=0.02]; and 5.5 vs 4.0 months mPFS [P=0.0003]; n=272 vs n=271, respectively).2 In the Phase 3 ASCENT study (pretreated mTNBC), TRODELVY demonstrated a proven survival benefit vs single-agent chemotherapy (brain-met–negative) (5.6 vs 1.7 months mPFS [P<0.001] and 12.1 vs 6.7 months mOS [P<0.001], n=235 vs n=233, respectively).3
aAccelerated approval in 2020 and full approval in 2021 (pretreated mTNBC).4
TROPiCS-02 was a Phase 3, randomized, active-controlled, open-label study (N=543) of patients with HR+/HER2- mBC who were previously treated with ≥1 endocrine therapy, a CDK4/6 inhibitor and a taxane in any setting, and who had received 2 to 4 lines of chemotherapy in the metastatic setting. The study assessed progression-free survival (PFS) by BICR per the RECIST v1.1 criteria (primary endpoint) and overall survival (secondary endpoint). Patients were randomized (1:1) to receive TRODELVY 10 mg/kg as an IV infusion on Days 1 and 8 of a 21-day cycle (n=272) or physician’s choice of single-agent chemotherapy (n=271), which included eribulin, vinorelbine, gemcitabine, or capecitabine. Patients were treated until disease progression or unacceptable toxicity.2,7
Read more about TROPiCS-02ASCENT was a Phase 3, randomized, active-controlled, open-label study (N=529) in patients with unresectable locally advanced or mTNBC who had relapsed after at least 2 prior chemotherapies, at least one of them for metastatic disease. The efficacy analysis included progression-free survival (PFS) in brain-met-negative patients by BICR per the RECIST v1.1 criteria (primary endpoint), with PFS for the full population (all patients with and without brain metastases) and overall survival (OS) as secondary endpoints. Patients were randomized (1:1) to receive TRODELVY 10 mg/kg as an IV infusion on Days 1 and 8 of a 21-day cycle (n=267) or physician’s choice of single-agent chemotherapy (n=262), which included eribulin, vinorelbine, gemcitabine, or capecitabine. Patients were treated until disease progression or unacceptable toxicity.2,3
- 88% of patients in the full population were brain-met–negative2,3
Sacituzumab govitecan-hziy (TRODELVY)
NCCN Category 1 preferred regimen
The only NCCN CATEGORY 1 PREFERRED Trop-2–directed ADC regimen for both pretreated HR+/HER2- mBC and mTNBC (HR-/HER2-)1
mTNBC (HR-/HER2-)
HR+/HER2- mBC
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
Category 1 indicates that based upon high-level evidence (≥1 randomized phase 3 trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.1
The NCCN recommendations differ from the sacituzumab govitecan-hziy (TRODELVY) Prescribing Information.
Discover TRODELVY, with 5+ years of real-world experiencec and an estimated
32,000 patientsd treated in the US4,8
cAccelerated approval in 2020 and full approval in 2021 (pretreated mTNBC).4
dEstimate as of October 2025 was based on assumptions including number of vials sold.8
Starting a patient on TRODELVY? Begin with these topics
2L=second line; ADC=antibody-drug conjugate; BICR=blinded independent central review; CDK4/6i=cyclin-dependent kinase 4/6 inhibitor; HR=hormone receptor; HER2=human epidermal growth factor receptor 2; IHC=immunohistochemistry; ISH=in situ hybridization; mBC=metastatic breast cancer; mOS=median overall survival; mPFS=median progression-free survival; mTNBC=metastatic triple-negative breast cancer; NCCN=National Comprehensive Cancer Network; OS=overall survival; PFS=progression-free survival; RECIST=response evaluation criteria in solid tumors; Trop-2=trophoblast cell-surface antigen-2; US=United States.
References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed October 20, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. TRODELVY. Prescribing Information. Gilead Sciences, Inc.; March 2025. 3. Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529-1541. 4. FDA Approves TRODELVY, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival. 2021. Accessed July 25, 2025. Available at: https://www.gilead.com/news/news-details/2021/fda-approves-trodelvy-the-first-treatment-for-metastatic-triple-negative-breast-cancer-shown-to-improve-progression-free-survival-and-overall-survival 5. Bardia A, Tolaney SM, Punie K, et al. Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. Ann Oncol. 2021;32(9):1148‐1156. 6. Rugo HS, Bardia A, Marmé F, et al. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2023;402(10411):1423-1433. 7. Rugo HS, Bardia A, Marmé F, et al. Sacituzumab govitecan in hormone receptor–positive/human epidermal growth factor receptor 2–negative metastatic breast cancer. J Clin Oncol. 2022;40(29):3365-3376. 8. Data on file. Gilead Sciences, Inc. October 2025.
TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:
- Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
- Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Important Safety Information
Tap for Important Safety Information, including BOXED WARNING: Neutropenia and Diarrhea.
Boxed Warning: neutropenia and diarrhea
- TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 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.
- 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.
Contraindications
- Severe hypersensitivity reaction to TRODELVY.
Warnings and precautions
Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.
Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.
Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.
Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.
Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.
Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.
Adverse Reactions
In the pooled safety population, the most common (≥25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).
In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.
In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.
Drug Interactions
UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.
UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.
Please see full Prescribing Information, including BOXED WARNING.