Boehringer’s HERNEXEOS® Wins Accelerated FDA Nod in Lung Cancer
In a landmark decision for HER2-mutant lung cancer, the US FDA has granted accelerated approval to Boehringer Ingelheim’s HERNEXEOS® (zongertinib), the first-ever oral targeted therapy for this hard-to-treat NSCLC subtype. The green light is backed by a 75% response rate in the Beamion-LUNG 1 trial, positioning Boehringer at the forefront of a fast-growing precision oncology niche.
The First Oral Precision Medicine Targeting HER2 Mutations in Lung Cancer
Boehringer Ingelheim announced on Friday that the The US Food and Drug Administration (FDA) has granted accelerated approval for HERNEXEOS® (zongertinib tablets), the first orally administered targeted therapy for adult patients with previously treated HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC).
The kinase inhibitor is indicated for patients with unresectable or metastatic non-squamous NSCLC harboring HER2 tyrosine kinase domain activating mutations, as identified through an FDA-approved test, following prior systemic therapy. Approval was based on an objective response rate (ORR) of 75% (N=71) in the Phase Ib Beamion-LUNG 1 trial. Continued approval may be contingent upon confirmatory trial results.
Strong Clinical Data from Beamion-LUNG 1
In the trial, 6% of patients achieved complete responses and 69% partial responses, with a duration of response ≥6 months in 58% of patients (n=53). Findings were presented at the 2025 AACR Annual Meeting and published in The New England Journal of Medicine.
Zongertinib showed a manageable safety profile with a 2.9% discontinuation rate. The most common adverse reactions (>20%) were diarrhea (53%), hepatotoxicity (27%), rash (27%), fatigue (22%), and nausea (21%).
Dr. John Heymach, MD, PhD, Chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center and coordinating investigator for Beamion-LUNG 1, said:
“With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2-mutant non-small cell lung cancer in the US that not only elicits a durable response but, importantly, has a manageable safety profile. In a patient population where there are currently limited treatment options, this approval represents a significant advancement in cancer care.”
Addressing a High-Unmet-Need Lung Cancer Subtype
HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with poor prognosis and increased risk of brain metastases. These alterations drive uncontrolled cell growth and tumor spread. Comprehensive biomarker testing with next-generation sequencing is essential to identify eligible patients.
Shashank Deshpande, Chairman of the Board of Managing Directors and Head of Human Pharma at Boehringer Ingelheim, commented:
“We are grateful to be able to bring forward HERNEXEOS, which has the potential to reset the benchmark for those living with HER2-mutant advanced non-small cell lung cancer, a condition associated with a particularly poor prognosis. Recognizing its potential, we accelerated development to deliver this new treatment option to patients within four years of starting the first clinical trial.”
Patient Advocacy Groups Welcome Approval
Patient advocacy organisations have praised the approval as a milestone in precision oncology.
Marcia Horn, President and CEO of the International Cancer Advocacy Network and Executive Director of the Exon 20 Group/HER2 Warriors, said:
“Understanding your cancer’s unique biomarkers, including HER2, through comprehensive testing is critical for all patients with NSCLC, as it can unlock targeted treatment options.”
About NSCLC and Zongertinib
NSCLC is the most common form of lung cancer, often diagnosed at advanced stages, with historically poor five-year survival rates below 10% for metastatic disease.
HERNEXEOS® (zongertinib tablets) is a selective HER2 tyrosine kinase inhibitor developed under the FDA’s Accelerated Approval Program, and also received Priority Review, Breakthrough Therapy, and Fast Track designations. Ongoing clinical studies are evaluating its potential across multiple HER2-altered solid tumors.
Boehringer Ingelheim continues to build its oncology portfolio by combining targeted therapies with immuno-oncology approaches to tackle some of the most challenging cancers.
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