Sevabertinib
Sevabertinib is an oral HER2 inhibitor for lung cancers with HER2 mutations, approved in November 2025 as an alternative to Enhertu and zongertinib.
Bayer's reversible HER2 TKI, derived from a Broad Institute alliance. SOHO-01: ORR ~64% in previously treated HER2-mutant NSCLC; accelerated approval 20 November 2025 for HER2 tyrosine-kinase-domain mutations after prior systemic therapy. First-line sNDA under priority review (2026). Diarrhoea and rash are the main toxicities; less ILD than T-DXd.
- 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: sevabertinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2025 | HER2 TKD-mutant non-squamous NSCLC after prior systemic therapy (accelerated) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Sevabertinib" OR ABSTRACT:"Sevabertinib" OR TITLE:"Hyrnuo" OR ABSTRACT:"Hyrnuo" OR TITLE:"BAY 2927088" OR ABSTRACT:"BAY 2927088") 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 Sevabertinib, not a curated reading list.
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