FDA grants accelerated approval to sevabertinib for first-line treatment of HER2-mutated non-small cell lung cancer.

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib (Hyrnuo) for the first-line treatment of locally advanced or metastatic nonsquamous non–small cell lung cancer (NSCLC) harboring HER2 tyrosine kinase domain (TKD)–activating mutations. This expands the drug's availability, as it previously received accelerated approval in November 2025 for patients who had received prior systemic therapy. The approval is supported by data from the phase 1/2 SOHO-01 trial, which showed an objective response rate of 75% in previously untreated patients.