On November 19, 2025, the US Food and Drug Administration (FDA) announced the accelerated approval of sevabertinib (Hyrnuo®) to treat patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) with specific mutations in the HER2 gene.
This approval is for patients who have been previously treated with HER2-targeted therapies, as well as patients who have received previous treatment that did not target HER2.
Mutations in the HER2 gene (also called the ERBB2 gene) are responsible for approximately 2%-3% of nonsquamous NSCLCs. These mutations activate the HER2 protein and drive cancer growth.
Sevabertinib is a type of targeted therapy that is given as a pill. It is a tyrosine kinase inhibitor (TKI) that disrupts the activity of the mutated HER2 protein to slow or stop cancer growth.
This FDA approval is supported by data from the phase 1/ 2 SOHO-01 clinical trial that was conducted internationally. The trial studied 70 patients who were previously treated with systemic therapy, but not HER2 targeted therapy. Data from the study showed 71% of patients had their tumors shrink or disappear with sevabertinib treatment (overall response rate). In addition, 54% of patients responded to treatment for 6 months or longer (duration of response).
The trial also studied 52 patients who were previously treated with systemic therapy and a different type of HER2-targeted treatment (an anti-body drug conjugate or ADC). In this group, 38% of patients had their tumors shrink or disappear with sevabertinib (overall response rate) and the response to treatment lasted 6 months or longer (duration of response) in 60% of patients.
It’s important to note that this is an accelerated approval intended to bring treatments to patients as quickly as possible. This drug continues to be tested in clinical trials.
For more information, please see the FDA’s press release.