On February 26, 2026, the US Food and Drug Administration (FDA) announced the accelerated approval of zongertinib (Hernexeos®) as an initial treatment option for newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) with mutations in the HER2 gene.
This approval expands the usage of this treatment from August 2025 when it was only approved for patients who have been previously treated with a systemic therapy (such as chemotherapy).
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.
Zongertinib 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 approval marks the first targeted therapy approved as an initial treatment for these patients.
This FDA approval is supported by data from the phase 1 Beamion Lung-1 clinical trial that was conducted internationally. The trial studied 72 newly diagnosed patients who had not yet been treated with systemic drugs. Data from the study showed 76% of patients had their tumors shrink or disappear with zongertinib treatment (overall response rate). In addition, 64% of patients responded to treatment for 6 months or longer (duration of response).
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 prescribing information and the FDA’s press release.