FDA Approves HERNEXEOS® Targeted Therapy for HER2-Mutant Lung Cancer

The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim's HERNEXEOS® (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations. This indication is approved under accelerated approval.

The approval is based on data from the Phase Ib Beamion LUNG-1 clinical trial, which showed an objective response rate of 76% in treatment-naïve patients. HERNEXEOS® also received prior accelerated FDA approval in August 2025 for previously treated patients.

HER2 mutations occur in approximately 2-4% of NSCLC cases and are associated with a poor prognosis and a higher incidence of brain metastases. The company states HERNEXEOS® now provides a targeted treatment option for these patients.

Experimental Drug Targets HER2-Mutated Cancer

Zongertinib is a small molecule, orally administered, targeted tyrosine kinase inhibitor designed to treat HER2 mutations. The dosage used in studies demonstrated promising results.

Boehringer Ingelheim is enrolling patients in Beamion LUNG-2, a confirmatory Phase III trial evaluating zongertinib as a first-line treatment for this patient population. The company aims to verify the drug's efficacy and safety in further studies.