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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.
Reversible, HER2-mutant-selective TKI sparing wild-type EGFR. Connects to HER2.
1.Sevabertinib slips into a pocket on HER2.
Sources: NICE search: sevabertinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.8 years later, when the FDA's table was read. source
Treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test
FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer The confirmatory requirement was still open 0.0 years later, when the FDA's table was read. source
| Region | Year | Indication |
|---|---|---|
| US | 2025 | HER2 TKD-mutant non-squamous NSCLC after prior systemic therapy (accelerated) |
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Query 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.
Shares Zongertinib, HER2-mutant non-small-cell lung cancer, Trastuzumab deruxtecan, HER2.
Shares Zongertinib, HER2-mutant non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares Zongertinib, HER2-mutant non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares HER2-mutant non-small-cell lung cancer, HER2, Non-small-cell lung cancer.
Shares Zongertinib, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares HER2-mutant non-small-cell lung cancer, HER2, Non-small-cell lung cancer.
Shares Zongertinib, Trastuzumab deruxtecan, Small-molecule kinase inhibitors.