On August 8, 2025, the US Food and Drug Administration (FDA) announced the accelerated approval of zongertinib (Hernexeos®) to treat patients with unresectable or metastatic non-small cell lung cancer (NSCLC) with mutations in the HER2 gene. This approval is 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 FDA approval is supported by data from the phase 1 Beamion Lung-1 clinical trial that was conducted internationally. The trial studied 71 patients who were previously treated with chemotherapy. Data from the study showed 75% of patients had their tumors shrink or disappear with zongertinib treatment (overall response rate). In addition, 58% of patients responded to treatment for 6 months or longer (duration of response).
The trial also studied 34 patients who were previously treated with chemotherapy and a different type of HER2-targeted treatment (an anti-body drug conjugate or ADC). In this group, 44% of patients had their tumors shrink or disappear with zongertinib (overall response rate) and the response to treatment lasted 6 months or longer (duration of response) in 27% 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.