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.