On September 9, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sevabertinib, marketed as Hyrnuo by Bayer. This approval is for the treatment of adult patients diagnosed with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain (TKD) activating mutations.

Sevabertinib represents a targeted therapy option specifically designed to address a genetic subset of NSCLC patients, providing a new treatment avenue for individuals whose tumors exhibit HER2 mutations.

The accelerated approval pathway demonstrates the FDA's commitment to facilitating patient access to promising treatments in areas of unmet medical need, while further clinical trials continue to confirm benefits and long-term outcomes.

This regulatory milestone highlights ongoing advancements in precision oncology and the importance of molecular profiling in lung cancer treatment decision-making.