HERNEXEOS Receives FDA Approval for Advanced HER2-Mutant NSCLC
The U.S. Food and Drug Administration has approved HERNEXEOS (zongertinib tablets), developed by Boehringer Ingelheim, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) whose tumours carry HER2 (ERBB2) tyrosine kinase domain activating mutations identified through an FDA-authorised test.
The approval was granted under the accelerated approval pathway and is based on objective response rate and duration of response.
Continued approval may depend on confirmation of clinical benefit in a Phase III study. The company is currently enrolling patients in the Beamion LUNG-2 trial, which is evaluating zongertinib as a first-line treatment for this patient group.
The decision is supported by results from the Phase Ib Beamion LUNG-1 trial, involving 72 treatment-naïve patients.
The study reported an objective response rate of 76%, including 11% complete responses and 65% partial responses. Around 64% of patients maintained a response for at least six months.
HER2 mutations occur in around 2–4% of NSCLC cases and are linked with poorer prognosis and higher rates of brain metastases.
Zongertinib is an irreversible tyrosine kinase inhibitor designed to target HER2 mutations and is taken as a once-daily oral treatment.
The therapy previously received accelerated approval in 2025 for patients with previously treated HER2-mutant advanced NSCLC.
