FDA Grants Accelerated Approval to Sevabertinib for Expanded Use in Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib (Hyrnuo) for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. This approval expands the drug's indication to include patients who have not received prior systemic therapy, based on results from the SOHO-01 clinical trial which showed a 75% objective response rate.