Sacituzumab tirumotecan
Sacituzumab tirumotecan is a third TROP2 ADC from China, licensed to Merck for a very large global programme. It is approved in China; in the US it has a priority voucher but not yet approval.
Kelun-Biotech's sac-TMT was approved by China's NMPA in 2024 for pretreated TNBC (the first TROP2 ADC approval in China) and later for EGFR-mutant NSCLC. Merck holds ex-Greater-China rights and runs the TroFuse programme of >10 phase 3 trials, including first-line TNBC (positive on primary endpoint per 2026 reports), HR+ breast, NSCLC, endometrial, and cervical cancer, many combined with pembrolizumab. FDA Breakthrough Therapy designation (EGFR-mutant NSCLC, 2024) and a Commissioner's National Priority Voucher (July 2026).
Sac-TMT carries T030, a belotecan-derived TOP1 inhibitor; belotecan shown.
1.Antibody binds TROP2 on the tumour cell surface
- Route
- IV infusion
- Schedule
- 5 mg/kg every 2 weeks (China label, TNBC); phase 3 trials use 4 mg/kg every 2 weeks in combination regimens
- Monitoring
- Blood counts; stomatitis and ocular surface care
Source: www.frontiersin.org/journals/oncology-reviews/articles/10.3389/or.2026.1781533/full. Doses are for orientation; the current label governs.
Compare all products across the US, EU, UK, Japan, China and Australia →
- May 2022Filing / dealChina
Merck licenses ex-Greater-China rights (deal expanded December 2022) source
- Nov 2024ApprovalChina
NMPA approval, pretreated advanced TNBC (OptiTROP-Breast01); first TROP2 ADC approved in China source
- 3 Dec 2024DesignationUS
Breakthrough Therapy designation, EGFR-mutant NSCLC after TKI source
- Mar 2025ApprovalChina
EGFR-mutant NSCLC after TKI failure source
- Jul 2026DesignationUS
Commissioner's National Priority Voucher (CNPV) awarded source
Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2024 | Pretreated advanced TNBC; later EGFR-mutant NSCLC after TKI |
| Adverse event |
|---|
| Neutropenia |
| Anaemia |
| Stomatitis |
| Nausea |
| Alopecia |
Most common grade ≥3 event in OptiTROP-Breast01; rates per publication. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| China | NMPA approved 2024; National Reimbursement Drug List inclusion from 2025 | not disclosed | — |
| United States | Investigational; not yet approved | 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)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Latest papers
topQuery for this drug: (TITLE:"Sacituzumab tirumotecan" OR ABSTRACT:"Sacituzumab tirumotecan" OR TITLE:"sac-TMT" OR ABSTRACT:"sac-TMT" OR TITLE:"MK-2870" OR ABSTRACT:"MK-2870" OR TITLE:"SKB264" OR ABSTRACT:"SKB264") 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 tirumotecan, not a curated reading list.