FDA Grants Accelerated Approval to Sevabertinib for HER2-Mutated Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. This approval expands the existing indication, allowing its use regardless of prior systemic therapy.