FDA Grants Accelerated Approval to Sevabertinib for First-Line Treatment of HER2-Mutant Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has expanded the accelerated approval of sevabertinib (Hyrnuo) 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 allows its use as a first-line treatment, building upon its previous accelerated approval for patients who had received prior systemic therapy. The decision is supported by findings from the SOHO-01 clinical trial, which demonstrated an objective response rate of 75% in treatment-naive patients. The prescribing information includes warnings and precautions for potential adverse reactions such as diarrhea, hepatotoxicity, interstitial lung disease, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity.