Hernexeos FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 10, 2025.
FDA Approved: Yes (First approved August 8, 2025)
Brand name: Hernexeos
Generic name: zongertinib
Dosage form: Tablets
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Non Small Cell Lung Cancer
Hernexeos (zongertinib) is a kinase inhibitor used for the treatment of non-squamous non-small cell lung cancer (NSCLC) with HER2 (ERBB2) tyrosine kinase domain activating mutations.
- Hernexeos is indicated for the treatment of adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
- 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. - NSCLC is the most common type of lung cancer. HER2 (ERBB2) mutations occur in approximately 2–4% of NSCLC cases and are associated with a poor prognosis and higher incidence of brain metastases. Alterations in the HER2 (ERBB2) gene, including mutations, amplification and overexpression, trigger uncontrolled cell proliferation, inhibiting cell death, and promoting tumor growth and spread.
- Hernexeos contains zongertinib, a tyrosine kinase inhibitor (TKI) that works by selectively inhibiting HER2 (ERBB2).
- Hernexeos was approved under the FDA’s Accelerated Approval Program, after securing Priority Review as well as Breakthrough Therapy and Fast Track Designations. Accelerated approval was based on data from the Phase Ib Beamion-LUNG 1 trial, demonstrating an objective response rate of 75% (N=71), 6% of patients had a complete response and 69% of patients had a partial response and a duration of response of ≥6 months in 58% of patients (n=53).
- Hernexeos tablets are administered orally, once daily with or without food until disease progression or unacceptable toxicity.
- Warnings and precautions associated with Hernexeos include hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.
- Common adverse reactions (≥ 20%) include diarrhea, hepatotoxicity, rash, fatigue, and nausea.
Common Grade 3 or 4 laboratory abnormalities (≥ 2%) include decreased lymphocytes, increased alanine aminotransferase, increased aspartate aminotransferase, decreased potassium, and increased gamma glutamyl transferase. - Zongertinib is also being evaluated in ongoing trials across a range of advanced solid tumors with HER2 alterations.
Development timeline for Hernexeos
Further information
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