On August 8, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, who have received prior systemic therapy.
Indication and Patient Selection
Eligible patients are those with HER2 TKD mutations confirmed via the FDA-approved companion diagnostic Oncomine Dx Target Test, following prior systemic therapy.
Clinical Trial Overview (Beamion LUNG-1)
Approval was based on results from Beamion LUNG-1 (NCT04886804), an open-label, multi-center, multi-cohort trial:
Dosage and Administration
Weight-based dosing:
Safety Information
Label includes warnings for hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.
Regulatory Pathway
The approval utilized the Real-Time Oncology Review (RTOR) pilot program and the Assessment Aid, and was granted priority review, breakthrough therapy designation, and fast track designation.
Conclusion and Outlook
Zongertinib offers a new treatment option for patients with HER2-mutated NSCLC. Ongoing real-world data will be critical to confirming long-term benefits and safety.
Source: FDA, AACR
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