Sacituzumab govitecan
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TNBC (ASCENT: OS 12.1 vs 6.7 months), 2023 for HR+/HER2- breast cancer (TROPiCS-02), and urothelial cancer (later withdrawn in the US after TROPiCS-04).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.
1.Antibody binds TROP2 on the tumour cell surface
- Route
- IV infusion
- Schedule
- 10 mg/kg on days 1 and 8 of each 21-day cycle
- Dose 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: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Gilead Advancing Access
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- Appraised for
- Unresectable triple-negative breast cancer after 2 or more systemic treatments
- Notes
- HR-positive/HER2-negative breast cancer (TROPiCS-02) appraised separately; check NICE.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA819 · SMC advice: sacituzumab govitecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 5 Feb 2016DesignationUS
Breakthrough Therapy designation for pretreated metastatic TNBC source
- 22 Apr 2020ApprovalUS
Accelerated approval, metastatic TNBC after ≥2 prior therapies source
- 7 Apr 2021ApprovalUS
Full approval in metastatic TNBC (ASCENT); accelerated approval in urothelial cancer source
- 22 Nov 2021ApprovalEU
EMA approval, pretreated metastatic TNBC source
- 3 Feb 2023ApprovalUS
HR+/HER2- metastatic breast cancer after endocrine therapy and ≥2 chemotherapies (TROPiCS-02) source
- Nov 2024WithdrawalUS
Urothelial cancer indication voluntarily withdrawn after TROPiCS-04 source
- Q2 2026ApprovalUS
First-line metastatic TNBC: monotherapy (PD-1 ineligible, ASCENT-03) and with pembrolizumab (CPS ≥10, ASCENT-04) source
Approvals
| 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) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia | 78% | 49% |
| Anaemia | 94% | 9% |
| Fatigue | 65% | 6% |
| Diarrhoea | 59% | 11% |
| Nausea | 57% | 3.1% |
| Alopecia | 47% | 0% |
| Constipation | 37% | 0.4% |
| Vomiting | 33% | 1.6% |
| Decreased appetite | 28% | 1.6% |
| Rash | 12% | 0.4% |
ASCENT, Trodelvy arm, n=258. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductDatopotamab deruxtecan
Shares Caution: TOP1 ADC immediately after TOP1 ADC, Neoadjuvant ADC + IO replacing anthracycline chemotherapy in TNBC, Require head-to-head trials against the best in class for later entrants, TROP2 PET → TROP2 ADC selection.
- ProductSacituzumab tirumotecan
Shares TROP2 PET → TROP2 ADC selection, TROP2 PET to choose and sequence TROP2 ADCs, TROP2 PET, Topoisomerase-I inhibitor payloads.
- TermADC sequencing
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.
- TermDXd
Shares Bystander effect (ADC), Topoisomerase-I inhibitor payloads, DNA replication & origin licensing, Drug efflux pumps (ABC transporters).
- TermExatecan (and derivatives)
Shares Topoisomerase-I inhibitor payloads, DNA replication & origin licensing, Drug efflux pumps (ABC transporters), Payload (ADC).
- RoadmapTNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line
Shares ASCENT-03, ASCENT, ASCENT-04 / KEYNOTE-D19, ADC for residual disease after KEYNOTE-522.
- ProductTrastuzumab deruxtecan
Shares Tumour-on-a-chip with blood flow to test whether big drugs actually get in, Caution: TOP1 ADC immediately after TOP1 ADC, Dose and schedule optimisation trials specific to antibody-drug conjugates, Sequential multiple-assignment randomised trials to find the best order of ADCs.
- ProductAK146D1
Shares Topoisomerase-I inhibitor payloads, TROP2 ADC roadmap: sacituzumab govitecan → Dato-DXd → sac-TMT → bispecifics and PET, ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs, TROP2.