Regulatory approval

Published by the Food and Drug Administration. Accelerated

HERNEXEOS is a kinase inhibitor indicated for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test. This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

This is written in the approval document.

Citation

Boehringer Ingelheim Pharmaceuticals, Inc. Hernexeos (zongertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219042s001lbl.pdf. Revised February 2026. Accessed March 2, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ERBB2 TKD activating variants	Lung Non-Squamous Non-Small Cell Carcinoma	Zongertinib

Contributions

Date	Contributor	Description
2026-02-26	Food and Drug Administration	The clinical eligibility criteria for this indication were expanded on 2026-02-26 by removing the prior therapy restriction.
2025-09-03	Van Allen lab	The US FDA approved zongertinib for the treatment of zongertinib for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.
2025-08-08	Food and Drug Administration	Indication received accelerated approval.