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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.
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TNBC (ASCENT: OS 12.1 vs 6.7 months), 2023 for HR+/HER2- breast cancer (TROPiCS-02), and urothelial cancer (later withdrawn in the US after TROPiCS-04).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.
Humanised anti-TROP2 IgG1 (hRS7) internalised; SN-38 released by linker hydrolysis inside and around tumour cells. Connects to TROP2.
1.Antibody binds TROP2 on the tumour cell surface
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9317.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA819 · SMC advice: sacituzumab govitecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2020-09-13 | Immunomedics to Gilead Sciences (incl. Kite) Sacituzumab govitecan (Trodelvy), TROP2 ADC | Acquisition | not disclosed | $21bn | source |
Tests the ADC as the first chemotherapy after endocrine therapy. Timing is a registry-based estimate. Source
Breakthrough Therapy designation for pretreated metastatic TNBC source
Adults with metastatic TNBC following at least 2 prior therapies for metastatic disease
Accelerated approval, metastatic TNBC after ≥2 prior therapies source
Adults with metastatic TNBC following at least 2 prior therapies for metastatic disease
Full approval in metastatic TNBC (ASCENT); accelerated approval in urothelial cancer source
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
Accelerated approval on a surrogate endpoint, with a confirmatory trial required. source
EMA approval, pretreated metastatic TNBC source
HR+/HER2- metastatic breast cancer after endocrine therapy and ≥2 chemotherapies (TROPiCS-02) source
Urothelial cancer indication voluntarily withdrawn after TROPiCS-04 source
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
Withdrawn: the indication came off the label 3.6 years after its accelerated approval. source
First-line metastatic TNBC: monotherapy (PD-1 ineligible, ASCENT-03) and with pembrolizumab (CPS ≥10, ASCENT-04) source
| Region | Year | Indication |
|---|---|---|
| US | 2020 | Metastatic TNBC, ≥2 prior lines (accelerated; full 2021) |
| US | 2023 | HR+/HER2- metastatic breast cancer after endocrine therapy and ≥2 chemotherapies |
| US | 2026 | First-line metastatic TNBC: monotherapy (PD-1 ineligible) or with pembrolizumab (PD-L1 CPS ≥10) |
| EU | 2021 | mTNBC ≥2 lines; HR+ 2023 |
| 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 · https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy |
| 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 · https://www.ema.europa.eu/en/medicines/human/EPAR/trodelvy |
| 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 · https://www.nice.org.uk/guidance/ta819 |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia ASCENT, Trodelvy arm, n=258 | 78% | 49% |
| Anaemia ASCENT, Trodelvy arm, n=258 | 94% | 9% |
| Fatigue ASCENT, Trodelvy arm, n=258 | 65% | 6% |
| Diarrhoea ASCENT, Trodelvy arm, n=258 | 59% | 11% |
| Nausea ASCENT, Trodelvy arm, n=258 | 57% | 3.1% |
| Alopecia ASCENT, Trodelvy arm, n=258 | 47% | 0% |
| Constipation ASCENT, Trodelvy arm, n=258 | 37% | 0.4% |
| Vomiting ASCENT, Trodelvy arm, n=258 | 33% | 1.6% |
| Decreased appetite ASCENT, Trodelvy arm, n=258 | 28% | 1.6% |
| Rash ASCENT, Trodelvy arm, n=258 | 12% | 0.4% |
| Neutropenia (grade 3 or higher) ASCENT, sacituzumab arm; 33 percent with chemotherapy | - | 51% |
| Diarrhoea (grade 3 or higher) ASCENT; below 1 percent with chemotherapy | - | 10% |
| Febrile neutropenia (grade 3 or higher) ASCENT; 2 percent with chemotherapy | - | 6% |
Rates read from source 1source 2. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (antibody-drug conjugates with a topoisomerase-i payload) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | gileadadvancingaccess.com |
| United Kingdom | NICE: recommended for pretreated metastatic TNBC (TA819) and HR+/HER2- breast cancer after endocrine therapy and chemotherapy | not disclosed | - |
| European Union | EMA approved; national reimbursement varies | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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PD-L1 testing with the combined positive score decides first-line treatment in metastatic triple-negative breast cancer; pembrolizumab-chemotherapy is the standard for scores of 10 or more.
Sacituzumab govitecan is a standard second-line or later treatment for metastatic triple-negative breast cancer, roughly doubling survival compared with the chemotherapies it was tested against. Patients should expect neutropenia and diarrhoea, which are manageable with growth factor support and loperamide. Trials are now testing it earlier, in first-line combinations with pembrolizumab and after surgery for residual disease.
TROP2 IHC does not gate sacituzumab govitecan: the label requires no test, and the corpus records TROP2 as an expression readout without a threshold.
Query for this drug: (TITLE:"Sacituzumab govitecan" OR ABSTRACT:"Sacituzumab govitecan" OR TITLE:"Trodelvy" OR ABSTRACT:"Trodelvy" OR TITLE:"IMMU-132" OR ABSTRACT:"IMMU-132") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sacituzumab govitecan, not a curated reading list.
Shares Living with an antibody-drug conjugate: diarrhoea, blood counts, eyes and lungs, Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer, Require head-to-head trials against the best in class for later entrants, Caution: TOP1 ADC immediately after TOP1 ADC.
Shares Scalp Cooling in MBC, Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Lo, Living with an antibody-drug conjugate: diarrhoea, blood counts, eyes and lungs, Tumour-on-a-chip with blood flow to test whether big drugs actually get in.
Shares Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy, NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer, TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG/I) in Early Triple-negative Breast Cancer, First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients..
Shares Caution: TOP1 ADC immediately after TOP1 ADC, Sequential multiple-assignment randomised trials to find the best order of ADCs, Topoisomerase-I inhibitor payloads, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET.
Shares TROP2 PET → TROP2 ADC selection, TROP2 expression, Topoisomerase-I inhibitor payloads, TROP2 PET to choose and sequence TROP2 ADCs.
Shares HER2-low eligibility for trastuzumab deruxtecan, and TROP2 ADCs without a test (triple-negative disease), Palliation in advanced triple-negative breast cancer: brain, bone, pleura, skin and end of life, A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer, HER2-low and HER2-ultralow metastatic breast cancer.
Shares DIAMOND, TROP2 PET to choose and sequence TROP2 ADCs, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, A randomised trial of antibody-drug conjugate sequence in metastatic triple-negative breast cancer.
Shares ADC + checkpoint inhibitor, DIAMOND, Trials that include, and report, brain metastases in triple-negative breast cancer, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET.