# Sevabertinib

Source: https://onco.cc/drugs/sevabertinib/  
OnCo record `sevabertinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Sevabertinib is an oral HER2 inhibitor for lung cancers with HER2 mutations, approved in November 2025 as an alternative to Enhertu and zongertinib.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-06
- Brand: Hyrnuo
- Code: BAY 2927088
- Modality: Small-molecule kinase inhibitor (HER2)
- Mechanism: Reversible, HER2-mutant-selective TKI sparing wild-type EGFR.
- Approvals: US 2025: HER2 TKD-mutant non-squamous NSCLC after prior systemic therapy (accelerated)

## Sources

- FDA approval (Bayer): https://www.bayer.com/en/us/news-stories/hyrnuo
- OncLive report: https://www.onclive.com/view/fda-grants-accelerated-approval-to-sevabertinib-in-her2-mutated-nonsquamous-nsclc

## Connected records

- cancers: [HER2-mutant non-small-cell lung cancer](https://onco.cc/cancers/her2-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [HER2](https://onco.cc/targets/her2/)
- drugs: [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/), [Zongertinib](https://onco.cc/drugs/zongertinib/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- trials: [A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-sma](https://onco.cc/trials/nct06452277/), [SOHO-01](https://onco.cc/trials/soho-01/)

---
JSON: https://onco.cc/api/v1/entities/sevabertinib.json