Trastuzumab rezetecan
Hengrui's HER2 ADC, approved in China for lung cancer and showing Enhertu-scale results in breast cancer, part of a wave of Chinese ADCs heading for global trials.
NMPA approval May 2025 for HER2-mutant NSCLC (HORIZON-Lung: ORR 74.5%, PFS 11.5 months). HORIZON-Breast01 (HER2+ breast after trastuzumab/taxane): PFS 30.6 vs 8.3 months vs pyrotinib + capecitabine (HR 0.22). Also active in HER2-low breast cancer and as neoadjuvant therapy; global phase 1 (HORIZON-X) reported 2026. ILD ~3-5%.
Trastuzumab rezetecan (SHR-A1811) carries a camptothecin-derived TOP1 inhibitor; exatecan shown as the class representative.
- Route
- Intravenous
- Schedule
- 4.8 mg/kg every 3 weeks (breast); 4.8-6.4 mg/kg studied
- Medicare
- Not covered (not FDA-approved)
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
- Commercial insurance
- unknown
Not FDA-approved, so there is no US coverage; access is only through a clinical trial or an FDA expanded-access request.
Sources: CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: trastuzumab rezetecan. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- May 2025ApprovalChina
HER2-mutant NSCLC source
Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2025 | HER2-mutant NSCLC after ≥1 systemic therapy (May 2025) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Neutropenia | — | 40% |
| Nausea | 60% | — |
| Interstitial lung disease | 4% | — |
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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Trastuzumab rezetecan" OR ABSTRACT:"Trastuzumab rezetecan" OR TITLE:"SHR-A1811" OR ABSTRACT:"SHR-A1811") 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 Trastuzumab rezetecan, not a curated reading list.
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