{"entity":{"id":"sacituzumab-govitecan","kind":"drug","name":"Sacituzumab govitecan","aka":[],"tldr":"The first TROP2-targeted ADC. It delivers a strong chemotherapy directly to breast and bladder cancer cells and is now a first-line option in triple-negative breast cancer.","summary":"Approved 2020 (accelerated) and 2021 (full) for pretreated metastatic TNBC (ASCENT: OS 12.1 vs 6.7 months), 2023 for HR+/HER2- breast cancer (TROPiCS-02), and urothelial cancer (later withdrawn in the US after TROPiCS-04). In 2026 the FDA approved it in first-line metastatic TNBC as monotherapy for patients not eligible for PD-1 inhibitors (ASCENT-03) and in combination with pembrolizumab for PD-L1-positive disease (ASCENT-04). Hydrolysable linker releases SN-38 in the tumour microenvironment, giving bystander killing. Neutropenia and diarrhoea are the key toxicities; UGT1A1*28 homozygotes are at higher risk.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Sacituzumab_govitecan","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Sacituzumab%20govitecan"},{"label":"NICE TA819: sacituzumab govitecan for unresectable triple-negative advanced breast cancer after 2 or more therapies (17 August 2022)","url":"https://www.nice.org.uk/guidance/ta819"},{"label":"Trodelvy label (openFDA): first-line and later-line TNBC indications, ASCENT-03 study section","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22TRODELVY%22"},{"label":"EMA Trodelvy product page: EU therapeutic indications","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy"}],"tags":[],"related":["pd-l1-cps"],"cancers":["tnbc","breast-hr-positive","urothelial","tnbc-metastatic"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["trop2"],"drugs":[],"companies":["gilead"],"institutions":[],"pathways":[],"terms":["bystander-effect","payload","cl2a"],"trials":["ascent","ascent-03","ascent-04","nct05089734","nct06801834","nct06486441","nct05633667","nct05186974","nct06926920","nct03547973","nct05840211","nct05119907","nct05609968","nct05101096","nct04454437","nct03964727","nct04639986","nct05327530","nct06827613","diamond"],"people":[],"bottlenecks":[],"keyPapers":["paper-bardia-ascent-trop2-biomarker-ann-oncol-2021","paper-keynote-355-nejm-2022"],"journals":[],"dependsOn":[],"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)."],"brand":"Trodelvy","code":"IMMU-132","modality":"ADC","payload":"SN-38 (topoisomerase-I inhibitor), DAR ~7.6","linker":"CL2A, pH-sensitive cleavable","mechanism":"Humanised anti-TROP2 IgG1 (hRS7) internalised; SN-38 released by linker hydrolysis inside and around tumour cells.","approvals":[{"region":"US","year":2020,"indication":"Metastatic TNBC, ≥2 prior lines (accelerated; full 2021)"},{"region":"US","year":2023,"indication":"HR+/HER2- metastatic breast cancer after endocrine therapy and ≥2 chemotherapies"},{"region":"US","year":2026,"indication":"First-line metastatic TNBC: monotherapy (PD-1 ineligible) or with pembrolizumab (PD-L1 CPS ≥10)"},{"region":"EU","year":2021,"indication":"mTNBC ≥2 lines; HR+ 2023"},{"region":"EU","year":2021,"indication":"Unresectable or metastatic TNBC after two or more systemic therapies, at least one for advanced disease (ASCENT); marketing authorisation issued 22 November 2021","note":"https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy"},{"region":"EU","year":2026,"indication":"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","note":"https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy"},{"region":"UK","year":2022,"indication":"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","note":"https://www.nice.org.uk/guidance/ta819"}],"mechanismSteps":["Antibody binds TROP2 on the tumour cell surface","Receptor-ADC complex is internalised by endocytosis","Trafficked to the lysosome; linker is cleaved or antibody degraded","SN-38 is released inside the cell","Topoisomerase-I is trapped on DNA; replication forks collapse into double-strand breaks","Tumour cell dies by apoptosis","Membrane-permeable payload diffuses to kill neighbouring antigen-negative cells (bystander effect)"],"dosing":{"route":"IV infusion","schedule":"10 mg/kg on days 1 and 8 of each 21-day cycle","modifications":"Hold and reduce for grade 3-4 neutropenia or diarrhoea; G-CSF prophylaxis permitted","monitoring":"Blood counts each dose; UGT1A1*28 homozygotes have earlier and more frequent neutropenia; anti-emetic premedication","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d"},"toxicity":[{"event":"Neutropenia","anyGradePct":78,"grade3PlusPct":49,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Anaemia","anyGradePct":94,"grade3PlusPct":9,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Fatigue","anyGradePct":65,"grade3PlusPct":6,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Diarrhoea","anyGradePct":59,"grade3PlusPct":11,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Nausea","anyGradePct":57,"grade3PlusPct":3.1,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Alopecia","anyGradePct":47,"grade3PlusPct":0,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Constipation","anyGradePct":37,"grade3PlusPct":0.4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Vomiting","anyGradePct":33,"grade3PlusPct":1.6,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Decreased appetite","anyGradePct":28,"grade3PlusPct":1.6,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Rash","anyGradePct":12,"grade3PlusPct":0.4,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=57a597d2-03f0-472e-b148-016d7169169d","note":"ASCENT, Trodelvy arm, n=258"},{"event":"Neutropenia (grade 3 or higher)","grade3PlusPct":51,"source":"https://doi.org/10.1056/NEJMoa2028485","note":"ASCENT, sacituzumab arm; 33 percent with chemotherapy"},{"event":"Diarrhoea (grade 3 or higher)","grade3PlusPct":10,"source":"https://doi.org/10.1056/NEJMoa2028485","note":"ASCENT; below 1 percent with chemotherapy"},{"event":"Febrile neutropenia (grade 3 or higher)","grade3PlusPct":6,"source":"https://doi.org/10.1056/NEJMoa2028485","note":"ASCENT; 2 percent with chemotherapy"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.gileadadvancingaccess.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for pretreated metastatic TNBC (TA819) and HR+/HER2- breast cancer after endocrine therapy and chemotherapy","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"},{"country":"EU","reimbursement":"EMA approved; national reimbursement varies","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2016-02-05","type":"designation","region":"US","note":"Breakthrough Therapy designation for pretreated metastatic TNBC","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2020-04-22","type":"accelerated-approval","region":"US","note":"Accelerated approval, metastatic TNBC after ≥2 prior therapies","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Adults with metastatic TNBC following at least 2 prior therapies for metastatic disease"},{"date":"2021-04-07","type":"conversion","region":"US","note":"Full approval in metastatic TNBC (ASCENT); accelerated approval in urothelial cancer","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Adults with metastatic TNBC following at least 2 prior therapies for metastatic disease"},{"date":"2021-04-13","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer","indication":"Treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor"},{"date":"2021-11-22","type":"approval","region":"EU","note":"EMA approval, pretreated metastatic TNBC","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2023-02-03","type":"approval","region":"US","note":"HR+/HER2- metastatic breast cancer after endocrine therapy and ≥2 chemotherapies (TROPiCS-02)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-11","type":"withdrawal","region":"US","note":"Urothelial cancer indication voluntarily withdrawn after TROPiCS-04","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2024-11-22","type":"withdrawal","region":"US","note":"Withdrawn: the indication came off the label 3.6 years after its accelerated approval.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer","indication":"Treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor"},{"date":"2026-06-24","type":"approval","region":"US","note":"First-line metastatic TNBC: monotherapy (PD-1 ineligible, ASCENT-03) and with pembrolizumab (CPS ≥10, ASCENT-04)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line"}]},"route":"/drugs/sacituzumab-govitecan/","neighbours":{"biomarker":[{"id":"pd-l1-cps","kind":"biomarker","name":"PD-L1 CPS (combined positive score)","route":"/biomarkers/pd-l1-cps/"},{"id":"trop2-expression","kind":"biomarker","name":"TROP2 expression","route":"/biomarkers/trop2-expression/"}],"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"her2-low-metastatic-breast-cancer","kind":"cancer","name":"HER2-low and HER2-ultralow metastatic breast cancer","route":"/cancers/her2-low-metastatic-breast-cancer/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast 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fill)","route":"/technologies/adc-supply-chain/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"},{"id":"trop2-pet","kind":"technology","name":"TROP2 PET","route":"/technologies/trop2-pet/"},{"id":"ugt1a1-genotyping","kind":"technology","name":"UGT1A1 genotyping before irinotecan","route":"/technologies/ugt1a1-genotyping/"}],"target":[{"id":"top1","kind":"target","name":"Topoisomerase I (TOP1)","route":"/targets/top1/"},{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"company":[{"id":"gilead","kind":"company","name":"Gilead Sciences (incl. Kite)","route":"/companies/gilead/"}],"term":[{"id":"bystander-effect","kind":"term","name":"Bystander effect (ADC)","route":"/terms/bystander-effect/"},{"id":"cl2a","kind":"term","name":"CL2A","route":"/terms/cl2a/"},{"id":"hair-loss-and-scalp-cooling-breast","kind":"term","name":"Hair loss and scalp cooling with breast cancer chemotherapy","route":"/terms/hair-loss-and-scalp-cooling-breast/"},{"id":"her2-low-and-trop2-adc-eligibility-tnbc","kind":"term","name":"HER2-low eligibility for trastuzumab deruxtecan, and TROP2 ADCs without a test (triple-negative disease)","route":"/terms/her2-low-and-trop2-adc-eligibility-tnbc/"},{"id":"adc-side-effects-breast","kind":"term","name":"Living with an antibody-drug conjugate: diarrhoea, blood counts, eyes and lungs","route":"/terms/adc-side-effects-breast/"},{"id":"neutropenic-sepsis-breast-chemotherapy","kind":"term","name":"Neutropenic sepsis: the temperature rule and the 999 signs","route":"/terms/neutropenic-sepsis-breast-chemotherapy/"},{"id":"tnbc-symptom-control-palliation","kind":"term","name":"Palliation in advanced triple-negative breast cancer: brain, bone, pleura, skin and end of life","route":"/terms/tnbc-symptom-control-palliation/"},{"id":"payload","kind":"term","name":"Payload (ADC)","route":"/terms/payload/"},{"id":"tnbc-residual-disease-decision","kind":"term","name":"Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point","route":"/terms/tnbc-residual-disease-decision/"},{"id":"sn-38","kind":"term","name":"SN-38","route":"/terms/sn-38/"},{"id":"topoisomerase-i-payloads","kind":"term","name":"Topoisomerase-I inhibitor payloads","route":"/terms/topoisomerase-i-payloads/"}],"trial":[{"id":"nct06827613","kind":"trial","name":"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","route":"/trials/nct06827613/"},{"id":"nct06926920","kind":"trial","name":"A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer","route":"/trials/nct06926920/"},{"id":"nct07040644","kind":"trial","name":"A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC","route":"/trials/nct07040644/"},{"id":"nct05327530","kind":"trial","name":"A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)","route":"/trials/nct05327530/"},{"id":"ascent","kind":"trial","name":"ASCENT","route":"/trials/ascent/"},{"id":"ascent-03","kind":"trial","name":"ASCENT-03","route":"/trials/ascent-03/"},{"id":"ascent-04","kind":"trial","name":"ASCENT-04 / KEYNOTE-D19","route":"/trials/ascent-04/"},{"id":"ascent-05","kind":"trial","name":"ASCENT-05 / OptimICE-RD (AFT-65, GBG 119, NSABP B-63)","route":"/trials/ascent-05/"},{"id":"nct04639986","kind":"trial","name":"Asian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC)","route":"/trials/nct04639986/"},{"id":"nct04434040","kind":"trial","name":"Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)","route":"/trials/nct04434040/"},{"id":"nct05770531","kind":"trial","name":"Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy","route":"/trials/nct05770531/"},{"id":"diamond","kind":"trial","name":"DIAMOND","route":"/trials/diamond/"},{"id":"nct07299409","kind":"trial","name":"First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.","route":"/trials/nct07299409/"},{"id":"nct06081244","kind":"trial","name":"NeoAdj. 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