FDA Grants Accelerated Approval to Sevabertinib for Non-Squamous Non–Small Cell Lung Cancer

On November 19, 2025, the FDA granted accelerated approval to sevabertinib (Hyrnuo), a kinase inhibitor, for adults with locally advanced or metastatic non-squamous non–small cell lung cancer (NSCLC) with HER2 tyrosine kinase domain (TKD)-activating mutations, as identified by an FDA-approved test, who had received prior systemic therapy. The FDA also approved the Oncomine Dx Target Test as a companion diagnostic for detecting HER2 TKD-activating mutations.¹

Efficacy was evaluated in the SOHO-01 trial (NCT05099172), an open-label, single-arm, multicenter study. Among 70 patients with HER2 TKD mutations who had not received prior HER2-targeted therapy, the objective response rate (ORR) was 71%, with a median duration of response (DOR) of 9.2 months. In 52 patients previously treated with HER2-targeted antibody-drug conjugates, the ORR was 38%, with a median DOR of 7.0 months.

The prescribing information includes warnings for diarrhea, hepatotoxicity, interstitial lung disease/pneumonitis, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity. The recommended dose is 20 mg orally twice daily with food until disease progression or unacceptable toxicity.

Reference

1. US Food and Drug Administration. FDA grants accelerated approval to sevabertinib for non-squamous non–small cell lung cancer. November 19, 2025. Accessed November 30, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer