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# FDA Grants Accelerated Approval to Zongertinib for Lung Cancer
- URL: https://www.fdaweb.com/fda-grants-accelerated-approval-to-zongertinib-for-lung-cancer/
- Published: 2026-02-26T12:00:00.000Z
- Updated: 2026-09-14T13:34:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160729

FDA has granted Boehringer Ingelheim Pharmaceuticals an accelerated approval for Hernexeos (zongertinib) for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain-activating mutations, as detected by an FDA-authorized test. Zongertinib is a kinase inhibitor evaluated under the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program, which aims to accelerate review of therapies addressing national health priorities, according to an agency [release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell?utm%5Fmedium=email&utm%5Fsource=govdelivery).

The approval is based on data from Beamion LUNG-1 (NCT04886804), a single-arm, open-label, multi-center trial involving 72 patients with HER2-mutant NSCLC who had not received prior systemic therapy for advanced disease. The trial demonstrated a 76% objective response rate, with 64% of responders maintaining a response for at least six months and 44% for at least 12 months, as assessed by blinded independent review using RECIST v1.1 criteria, FDA says.

Safety warnings in the prescribing information highlight potential hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity, it says.