FDA

Hernexeos OK’d for first-line treatment of HER2-mutant non-small cell lung cancer

March 3, 2026

On February 26, 2026, FDA granted accelerated approval to Hernexeos (zongertinib), a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

Previously, Hernexeos was approved for patients who’d failed prior systemic therapy.

Efficacy

Efficacy was evaluated in Beamion LUNG-1 (NCT04886804), a phase 1b, single arm, open-label, multi-center, multi-cohort trial. The efficacy population included 72 patients with unresectable or metastatic, non-squamous NSCLC with HER2 (ERBB2) TKD mutations, who hadn’t received systemic therapy for advanced disease.

The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) determined by blinded independent central review per RECIST v1.1. ORR was 76% (95% confidence interval, 65-85), with 64% of responders having a DOR ≥6 months and 44% having a DOR ≥12 months.

Safety

The prescribing information includes warnings and precautions for hepatotoxicity, left ventricular dysfunction, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.

The most common adverse reactions (≥ 20%) include diarrhea, rash, hepatotoxicity, fatigue, nausea, musculoskeletal pain, and upper respiratory tract infection.

Recommended dose

The recommended zongertinib dosage is based on body weight. For patients weighing less than 90 kg, the dose is 120 mg orally once daily. For patients weighing 90 kg or more, the dose is 180 mg orally once daily. Zongertinib may be taken with or without food and continued until disease progression or unacceptable toxicity.

Source:

FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer. [News release]. 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell

FDA approves Hernexeos®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option. [News release]. 2026. https://www.boehringer-ingelheim.com/human-health/cancer/lung-cancer/fda-approves-hernexeos-first-line-lung-cancer

Hernexios (zongertinib) [package insert]. Food and Drug Adminisration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219042s001lbl.pdf Revised February 2026. Accessed March 2, 2026.