Adults newly diagnosed with advanced lung cancer driven by certain HER2 mutations can now receive sevabertinib, a twice-daily targeted pill, as their first treatment. The FDA granted accelerated approval on Sept. 9 to sevabertinib, sold by Bayer as Hyrnuo, for adults with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors carry HER2 tyrosine kinase domain activating mutations detected by an FDA-authorized test.
The decision expands a previous accelerated approval granted in November 2025, which limited the drug to patients who had already received systemic therapy. Eligible patients no longer have to try another treatment first.
