# Sacituzumab govitecan

Source: https://onco.cc/drugs/sacituzumab-govitecan/  
OnCo record `sacituzumab-govitecan` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Sacituzumab govitecan carries chemotherapy to cancer cells bearing TROP2. It is FDA-approved for specific advanced breast-cancer settings, including two first-line triple-negative indications.

## Summary

The June 2026 US label retains unresectable locally advanced or metastatic TNBC after at least two systemic therapies, at least one for metastatic disease, and HR-positive/HER2-negative advanced breast cancer after endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. On June 24, 2026, FDA approved first-line advanced TNBC monotherapy when PD-1/PD-L1 inhibitor therapy is unsuitable, and combination with pembrolizumab or pembrolizumab/berahyaluronidase alfa when PD-L1 CPS is at least 10 by an FDA-authorized test. The urothelial indication was withdrawn November 22, 2024. These indications do not establish postoperative recurrence prevention. The label has boxed warnings for neutropenia and diarrhea; a TROP2 companion test is not required.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-10-06
- Brand: Trodelvy
- Code: IMMU-132
- Modality: ADC
- Mechanism: Humanised anti-TROP2 IgG1 (hRS7) internalised; SN-38 released by linker hydrolysis inside and around tumour cells.
- Payload: SN-38 (topoisomerase-I inhibitor), DAR ~7.6
- Linker: CL2A, pH-sensitive cleavable
- Approvals: EU 2021: mTNBC ≥2 lines; HR+ 2023; US 2021: Adults with unresectable locally advanced or metastatic TNBC after at least two prior systemic therapies, including at least one for metastatic disease; US 2023: Adults with unresectable locally advanced or metastatic HR-positive/HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies in the metastatic setting; US 2026: First-line adults with unresectable locally advanced or metastatic TNBC who are not candidates for PD-1 or PD-L1 inhibitor-based therapy; monotherapy; US 2026: First-line adults with unresectable locally advanced or metastatic TNBC, PD-L1 CPS at least 10 by an FDA-authorized test, with pembrolizumab or pembrolizumab/berahyaluronidase alfa; EU 2021: Unresectable or metastatic TNBC after two or more systemic therapies, at least one for advanced disease (ASCENT); marketing authorisation issued 22 November 2021; EU 2026: First-line unresectable locally advanced or metastatic TNBC in patients who are not candidates for PD-1 or PD-L1 inhibitor therapy (ASCENT-03); listed in the EMA therapeutic indications read on 24 September 2026; UK 2022: Unresectable triple-negative locally advanced or metastatic breast cancer after two or more systemic therapies, at least one for advanced disease; NICE TA819 (17 August 2022) recommends within the marketing authorisation with a commercial arrangement
- Dosing: IV infusion; 10 mg/kg on days 1 and 8 of each 21-day cycle
- Toxicity (grade 3+): Neutropenia 49%; Anaemia 9%; Fatigue 6%; Diarrhoea 11%; Nausea 3.1%; Alopecia 0%; Constipation 0.4%; Vomiting 1.6%; Decreased appetite 1.6%; Rash 0.4%; Neutropenia (grade 3 or higher) 51%; Diarrhoea (grade 3 or higher) 10%; Febrile neutropenia (grade 3 or higher) 6%

## Notes

- Triple-negative breast cancer biomarkers: no TROP2 test is required; benefit in ASCENT was seen at high and medium Trop-2 H-score and regardless of germline BRCA (Bardia 2021). The first-line combination with pembrolizumab (ASCENT-04) is gated by 22C3 CPS 10 or more, the KEYNOTE-355 threshold (Cortes 2022); monotherapy first line (ASCENT-03) is for patients not candidates for PD-1 inhibitors.
- Triple-negative breast cancer, UK status: NICE TA819 covers third line and beyond. The first-line PD-L1-negative indication (ASCENT-03) is a NICE appraisal awaiting development (GID-TA11489, expected publication to be confirmed); no NICE appraisal of sacituzumab govitecan with pembrolizumab (ASCENT-04) was listed on 24 September 2026. The UK ASCENT sites were Colchester, Coventry, Durham, Guildford, Hereford, the Royal Free, the Christie, Nottingham, Plymouth, Taunton and Wakefield.
- Label toxicity, first line with pembrolizumab (ASCENT-04, 221 patients): decreased neutrophil count and haemoglobin 86 percent each, diarrhoea 72 percent, nausea 68 percent, alopecia 52 percent (Trodelvy label, adverse reactions).

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Sacituzumab_govitecan
- Current US label: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d
- FDA first-line TNBC approvals, June 24, 2026: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line
- FDA HR-positive indication, February 3, 2023: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer
- FDA urothelial withdrawal, November 22, 2024: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Sacituzumab%20govitecan
- NICE TA819: sacituzumab govitecan for unresectable triple-negative advanced breast cancer after 2 or more therapies (17 August 2022): https://www.nice.org.uk/guidance/ta819
- Trodelvy label (openFDA): first-line and later-line TNBC indications, ASCENT-03 study section: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TRODELVY%22
- EMA Trodelvy product page: EU therapeutic indications: https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy

## Connected records

- biomarkers: [PD-L1 CPS (combined positive score)](https://onco.cc/biomarkers/pd-l1-cps/), [TROP2 expression](https://onco.cc/biomarkers/trop2-expression/)
- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [HER2-low and HER2-ultralow metastatic breast cancer](https://onco.cc/cancers/her2-low-metastatic-breast-cancer/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [HR-positive metastatic breast cancer after CDK4/6 inhibitors](https://onco.cc/cancers/hr-positive-metastatic-post-cdk46/), [Inflammatory breast cancer](https://onco.cc/cancers/inflammatory-breast-cancer/), [Metaplastic breast carcinoma](https://onco.cc/cancers/metaplastic-breast-carcinoma/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [The ADC supply chain (antibody, payload-linker, conjugation, fill)](https://onco.cc/technologies/adc-supply-chain/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/), [TROP2 PET](https://onco.cc/technologies/trop2-pet/), [UGT1A1 genotyping before irinotecan](https://onco.cc/technologies/ugt1a1-genotyping/)
- targets: [Topoisomerase I (TOP1)](https://onco.cc/targets/top1/), [TROP2](https://onco.cc/targets/trop2/)
- companies: [Gilead Sciences (incl. Kite)](https://onco.cc/companies/gilead/)
- terms: [Bystander effect (ADC)](https://onco.cc/terms/bystander-effect/), [CL2A](https://onco.cc/terms/cl2a/), [Hair loss and scalp cooling with breast cancer chemotherapy](https://onco.cc/terms/hair-loss-and-scalp-cooling-breast/), [HER2-low eligibility for trastuzumab deruxtecan, and TROP2 ADCs without a test (triple-negative disease)](https://onco.cc/terms/her2-low-and-trop2-adc-eligibility-tnbc/), [Living with an antibody-drug conjugate: diarrhoea, blood counts, eyes and lungs](https://onco.cc/terms/adc-side-effects-breast/), [Neutropenic sepsis: the temperature rule and the 999 signs](https://onco.cc/terms/neutropenic-sepsis-breast-chemotherapy/), [Palliation in advanced triple-negative breast cancer: brain, bone, pleura, skin and end of life](https://onco.cc/terms/tnbc-symptom-control-palliation/), [Payload (ADC)](https://onco.cc/terms/payload/), [Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point](https://onco.cc/terms/tnbc-residual-disease-decision/), [SN-38](https://onco.cc/terms/sn-38/), [Topoisomerase-I inhibitor payloads](https://onco.cc/terms/topoisomerase-i-payloads/)
- trials: [A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors](https://onco.cc/trials/nct06827613/), [A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer](https://onco.cc/trials/nct06926920/), [A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC](https://onco.cc/trials/nct07040644/), [A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)](https://onco.cc/trials/nct05327530/), [ASCENT](https://onco.cc/trials/ascent/), [ASCENT-03](https://onco.cc/trials/ascent-03/), [ASCENT-04 / KEYNOTE-D19](https://onco.cc/trials/ascent-04/), [ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)](https://onco.cc/trials/ascent-05/), [Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)](https://onco.cc/trials/nct04639986/), [Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)](https://onco.cc/trials/nct04434040/), [Avelumab combinations in advanced TNBC](https://onco.cc/trials/nct03971409/), [Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy](https://onco.cc/trials/nct05770531/), [DIAMOND](https://onco.cc/trials/diamond/), [First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.](https://onco.cc/trials/nct07299409/), [NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)](https://onco.cc/trials/nct06081244/), [NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer](https://onco.cc/trials/nct07178730/), [Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer](https://onco.cc/trials/nct06616987/), [Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer](https://onco.cc/trials/nct07825753/), [Saci Nivo Rela for TNBC](https://onco.cc/trials/nct06963905/), [Sacituzumab Govitecan +/- Pembrolizumab in Metastatic TNBC](https://onco.cc/trials/nct04468061/), [Sacituzumab Govitecan and Q901 in Advanced TNBC](https://onco.cc/trials/nct07788222/), [Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases](https://onco.cc/trials/nct06238921/), [Sacituzumab Govitecan in Metastatic Colorectal Cancer](https://onco.cc/trials/nct06243393/), [Sacituzumab Govitecan in Primary HER2-negative Breast Cancer](https://onco.cc/trials/nct04595565/), [Sacituzumab Govitecan In TNBC](https://onco.cc/trials/nct04230109/), [Sacituzumab Govitecan Plus Bevacizumab in Metastatic TNBC](https://onco.cc/trials/nct07359404/), [Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer](https://onco.cc/trials/nct05552001/), [Scalp Cooling in MBC](https://onco.cc/trials/nct04986579/), [Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors](https://onco.cc/trials/nct06167317/), [Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)](https://onco.cc/trials/nct07011654/), [Study of Novel Treatment Combinations in Patients With Lung Cancer](https://onco.cc/trials/nct05633667/), [Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)](https://onco.cc/trials/nct05609968/), [Study of Sacituzumab Govitecan (SG) in Japanese Participants With Advanced Solid Tumors](https://onco.cc/trials/nct05101096/), [Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct05089734/), [Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)](https://onco.cc/trials/nct05186974/), [Study of Sacituzumab Govitecan in Chinese Patients With Metastatic Triple-negative Breast Cancer Who Received at Least Two Prior Treatments](https://onco.cc/trials/nct04454437/), [Study of Sacituzumab Govitecan in Participants With Advanced or Metastatic Solid Tumor and Moderate Liver Impairment](https://onco.cc/trials/nct04617522/), [Study of Sacituzumab Govitecan in Participants With Metastatic Solid Tumors](https://onco.cc/trials/nct03964727/), [Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread](https://onco.cc/trials/nct03547973/), [Study of Sacituzumab Govitecan in Patients With Solid Tumor](https://onco.cc/trials/nct05119907/), [Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer](https://onco.cc/trials/nct06801834/), [Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Im](https://onco.cc/trials/nct06486441/), [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](https://onco.cc/trials/nct05840211/), [Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer](https://onco.cc/trials/nct07339059/), [Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.](https://onco.cc/trials/nct06431633/), [Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer](https://onco.cc/trials/nct03606967/), [Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Lo](https://onco.cc/trials/nct07151586/), [TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer](https://onco.cc/trials/nct07271992/), [TROPiCS-02](https://onco.cc/trials/tropics-02/)
- key papers: [ASCENT: sacituzumab govitecan doubles survival in heavily pretreated metastatic triple-negative breast cancer](https://onco.cc/key-papers/paper-ascent-nejm-2021/), [Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer](https://onco.cc/key-papers/paper-bardia-ascent-trop2-biomarker-ann-oncol-2021/), [KEYNOTE-355: pembrolizumab plus chemotherapy for PD-L1-positive advanced triple-negative breast cancer](https://onco.cc/key-papers/paper-keynote-355-nejm-2022/)
- roadmaps: [ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs](https://onco.cc/roadmaps/adc-generations/), [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/), [TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET](https://onco.cc/roadmaps/trop2-adc-roadmap/)
- ideas: [A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer](https://onco.cc/ideas/idea-tnbc-adc-sequencing-trial/), [ADC for residual disease after KEYNOTE-522](https://onco.cc/ideas/idea-post-neoadjuvant-adc/), [ctDNA-guided adjuvant decisions after residual disease: escalate the positive, spare the negative](https://onco.cc/ideas/idea-tnbc-ctdna-guided-adjuvant-decisions/), [Dose and schedule optimisation trials specific to antibody-drug conjugates](https://onco.cc/ideas/idea-tr1-adc-dose-and-schedule-optimisation/), [Neoadjuvant ADC + IO replacing anthracycline chemotherapy in TNBC](https://onco.cc/ideas/idea-neoadjuvant-adc-io/), [Patient-derived organoids to pick ADC payloads](https://onco.cc/ideas/idea-organoid-guided-adc/), [Require head-to-head trials against the best in class for later entrants](https://onco.cc/ideas/idea-fund-head-to-head-mandate/), [Sequential multiple-assignment randomised trials to find the best order of ADCs](https://onco.cc/ideas/idea-tr2-smart-sequencing-adc/), [Trials that include, and report, brain metastases in triple-negative breast cancer](https://onco.cc/ideas/idea-tnbc-brain-metastasis-trials/), [TROP2 PET to choose and sequence TROP2 ADCs](https://onco.cc/ideas/idea-trop2-pet-selection/), [Tumour-on-a-chip with blood flow to test whether big drugs actually get in](https://onco.cc/ideas/idea-bio1-tumour-on-chip-penetration/)
- pairings: [ADC + checkpoint inhibitor](https://onco.cc/pairings/adc-plus-io/), [Caution: TOP1 ADC immediately after TOP1 ADC](https://onco.cc/pairings/adc-after-adc-caution/), [TROP2 PET → TROP2 ADC selection](https://onco.cc/pairings/trop2-pet-to-adc/)
- people: [Aditya Bardia](https://onco.cc/people/aditya-bardia/), [Hope S. Rugo](https://onco.cc/people/hope-rugo/), [Sara M. Tolaney](https://onco.cc/people/sara-tolaney/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/)
- pathways: [Breast cancer (KEGG map)](https://onco.cc/pathways/breast-cancer-signalling/), [DNA replication & origin licensing](https://onco.cc/pathways/dna-replication-licensing/), [Drug efflux pumps (ABC transporters)](https://onco.cc/pathways/drug-efflux-pumps/)

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