FDA accelerates approval of sevabertinib-Hyrnuo to treat non-squamous non-small cell lung cancer

On November 19, 2025, the U.S. Food and Drug Administration (FDA) announced accelerated approval of sevabertinib (sevabertinib), brand nameHyrnuo is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The approval applies to patients whose tumors exhibit activating mutations in the HER2 (ERBB2) tyrosine kinase domain (TKD) and who have received prior systemic therapy.

To ensure that patients are eligible for this new therapy, the FDA also approved the oncomine Dx Target Test (developed by Life Technologies Corporation) as an auxiliary diagnostic tool to detect HER2 (ERBB2) TKD activating mutations in patients with non-squamous non-small cell lung cancer who are eligible for sevabertinib treatment. The test could help doctors pinpoint patients suitable for treatment with the drug.

The drug's efficacy and safety were primarily assessed through a multicenter clinical trial calledSOHO-01 (NCT05099172). In this open-label, single-arm, multi-cohort study, researchers evaluated efficacy in patients with unresectable metastatic non-squamous NSCLC with HER2 (ERBB2) TKD-activating mutations. These patients had received systemic treatment before participating in the study.

In this trial, the primary efficacy endpoints were confirmed objective response rate (ORR) and duration of response (DOR) assessed by BICR using RECIST v1.1 criteria. Among 70 eligible patients, the ORR was 71% (95% CI: 59, 82), with a median DOR of 9.2 months (95% CI: 6.3, 15.0), with 54% of responders having a DOR ≥ 6 months. In addition, among 52 patients who had previously received treatment including a HER2-targeted antibody-drug conjugate, the ORR was 38% (95% CI: 25, 53), the median DOR was 7.0 months (95% CI: 5.6, not evaluable), and 60% of responding patients had a DOR ≥ 6 months. These data suggest that sevabertinib is effective in treatingSignificant efficacy in patients with HER2 (ERBB2) mutated non-squamous non-small cell lung cancer.

However, there are certain risks with using sevabertinib. The prescribing information lists possible side effects of the drug, including warnings and precautions for diarrhea, hepatotoxicity, interstitial lung disease (ILD)/pneumonitis, ocular toxicity, elevated pancreatic enzymes, and embryo-fetal toxicity. To minimize risk, the recommended dose is 20 mg twice daily with food until disease progression or unacceptable toxicity.

Taken together, the accelerated approval of sevabertinib marks a new treatment option for non-squamous NSCLC, especially for patients with HER2 mutations. With this approval from the FDA, doctors and patients can better take advantage of this new targeted treatment option and strive to improve patients' prognosis and quality of life.

Reference materials:https://en.wikipedia.org/wiki/Sevabertinib