FDA Approves Companion Diagnostic Test for Hernexeos in NSCLC

The U.S. Food and Drug Administration (FDA) has approved the Oncomine Dx Target Test which will be used to identify patients with HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC) who are eligible to be treated with Hernexeos (zongertinib tablets), according to a news release from Thermo Fisher Scientific, which noted that this is the first and only orally administered targeted treatment.

Notably, the regulatory agency approved Hernexeos — a tyrosine kinase inhibitor — treatment for people with with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 tyrosine kinase domain (TKD) activating mutations on August 8, 2025.

“This rare form of NSCLC is linked to a poor prognosis and limited treatment options, making HERNEXEOS an important advancement in addressing the unmet needs of patients,” said Vicky Brown, senior vice president and head of Immunology, Oncology, and Eye Health, at Boehringer Ingelheim. “Through our collaboration with Thermo Fisher and leveraging the company’s proven track record with companion diagnostics, we’re pleased that patients have another tool that can be used to identify those with HER2 (ERBB2) tyrosine kinase activating mutations in non-small cell lung cancer.”

The Oncomine Dx Target Test will be utilized as a companion diagnostic. This means that clinicians and pathologists will be able to assess if patients' tumors harbor the HER2/ERBB2 TKD activating mutations which would allow them to benefit from Hernexeos treatment.

The FDA first approved the Oncomine Dx Target Test as a next-generation sequencing (NGS) companion diagnostic in 2017. Since then, it has received regulatory clearance in 20 countries for 11 biomarkers and more than 20 targeted therapies, with availability varying by region. The test is reimbursed by government and commercial insurers in the United States, Europe, Japan, South Korea, and Israel.

In the United States, the Oncomine Dx Target Test is approved for use in targeted therapies for NSCLC, cholangiocarcinoma, astrocytoma, oligodendroglioma (OG), anaplastic thyroid cancer, medullary thyroid cancer, and thyroid cancer.

“The FDA's approval of HERNEXEOS for previously treated patients living with HER2 (ERBB2)-mutant advanced NSCLC signifies continued success in our efforts to develop timely and accessible companion diagnostics,” said Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific. “We’re continuing to expand our solutions for our pharma partners, as this approval quickly follows the recent FDA approval of our latest rapid NGS solution that can deliver results in as little as 24 hours.”

More Information on the Hernexeos FDA Approval

In the United States, the second most common cancer in both men and women is lung cancer; NSCLC accounts for approximately 85% to 90% of all lung cancer cases. Moreover, for those who are diagnoses with the disease, up to 4% of these diagnosed patients will present with a HER2 mutation.

The efficacy of Hernexeos was investigated the Beamion LUNG-1 clinical trial which evaluated among patients with previously treated, unresectable or metastatic non-squamous NSCLC; these patients’ tumors must have had a HER2 TKD mutations. Based on data reported from the Beamion LUNG-1 study, the objective response rate was 75% and the duration of response was at least six months for 58% among 71 patients who had received previous platinum-based chemotherapy but not a HER2-targewted kinase inhibitor or antibody-drug conjugate.

Contrarily, among 34 patients who were previously treated with both platinum-based chemotherapy and a HER2-targeting antibody-drug conjugate, the objective response rate was 44% and 27% of patients a duration of response of at least six months.

Notably, HER2 is a protein that can be overexpressed in cancers and ultimately can drive tumor growth. To combat this, Hernexeos inhibits HER2 signaling, which can lead to the death of tumor cells.

Reference

1. “Thermo Fisher Receives FDA Approval for NGS-Based Companion Diagnostic for New Non-Small Cell Lung Cancer Treatment,” by Thermo Fisher Scientific. News release. August 11, 2025.
2. “FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations,” FDA. Aug. 8, 2025.

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