sevabertinib

Sevabertinib is an investigational **oral small-molecule tyrosine kinase inhibitor** developed by **Bayer** for **HER2-mutant cancers**, with the lead indication in **advanced non-small cell lung cancer** harboring activating **HER2 mutations**. It is described as a **potent, reversible HER2 inhibitor** designed to target HER2 alterations including **exon 20 insertions and point mutations**, and it also has activity against **EGFR** with greater selectivity for mutant over wild-type EGFR. Clinical development has centered on the phase 1/2 **SOHO-01** study in HER2-mutant NSCLC, where sevabertinib has shown meaningful antitumor activity in previously treated and treatment-naive patients, and Bayer has also initiated broader development in other HER2-activating solid tumors, first-line HER2-mutant NSCLC, expanded access, and multiple clinical pharmacology studies. The drug has been reported as having received **FDA Breakthrough Therapy Designation** and **Priority Review** for previously treated advanced HER2-mutant NSCLC, but it has not been stated here to be approved in any country.

Brand names

Hyrnuo

Other names

BAY 2927088BAY2927088BAY-2927088sevabertinib