Sevabertinib, an investigational oral treatment, is under Priority Review by the FDA for patients with HER2+ non-small cell lung cancer (NSCLC) and other solid tumors harboring HER2-activating mutations. Developed through a research collaboration between Bayer and the Broad Institute of MIT and Harvard, Sevabertinib is a reversible tyrosine kinase inhibitor (TKI) specifically designed to target HER2 mutations, such as exon 20 insertions and point mutations, as well as EGFR mutations, with a higher preference for mutant EGFR variants over normal EGFR. Despite not having received approval for use in any country yet, Sevabertinib continues to undergo clinical evaluation and shows promise in addressing the unmet treatment needs of patients with HER2-mutated cancers.
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