FDA approves HERNEXEOS(R), the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option

The FDA granted zongertinib Breakthrough Therapy Designation for patients with HER2 (ERBB2)-mutant advanced NSCLC as an initial treatment. The FDA also awarded a Commissioner's National Priority ...
Medscape

Zongertinib Picks Up First-Line Metastatic NSCLC Indication

The accelerated approval for patients with HER2 (ERBB2)-mutated disease follows an approval last August for use after prior ...
MPR

Hernexeos Approval Expanded to Include Treatment-Naïve HER2-Mutant NSCLC

The approval was based on a cohort of treatment-naïve patients in the Beamion LUNG-1 trial who had unresectable or metastatic, non-squamous NSCLC with HER2 tyrosine kinase domain mutations.
CURE

FDA Approves Hernexeos for HER2-Mutant Non-Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has approved Hernexeos (zongertinib) for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have specific HER2 ...
The American Journal of Managed Care

FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant NSCLC

Today, the FDA granted accelerated approval to zongertinib (Hernexeos; Boehringer Ingelheim Pharmaceuticals, Inc.) for an expanded indication for adults with unresectable or metastatic non-squamous ...
PharmExec

FDA Approves Hernexeos Under National Priority Voucher Program

The approval comes under the National Priority Voucher Program, joining Augmentin XR as one of the few approvals from the voucher program as of February 27, 2026. Hernexeos was granted a national ...
News Medical

New blood test can accurately, quickly identify genetic mutations linked to NSCLC

Identification of a specific genetic mutation in patients with non-small-cell lung cancer (NSCLC) helps clinicians select the best treatment option. Potential NSCLC patients usually undergo invasive ...
ascopubs.org

Utilizing TP53 mutation status and initial disease burden at presentation to risk-stratify patients with advanced EGFR-mutated NSCLC treated with osimertinib.

Next generation sequencing (NGS) of malignant effusions and comparison to blood liquid biopsy (ctDNA): A community experience. Celecoxib vs placebo in combination with chemotherapy for non-small cell ...
Seeking Alpha

Lunit to Present AI Study on EGFR Mutation Prediction in NSCLC at AACR 2025 in Collaboration with AstraZeneca

AI-powered model predicts EGFR mutations from H&E-stained slides, demonstrating robust performance across diverse clinical settings and helping overcome barriers to molecular testing in NSCLC EGFR ...

FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option

This press release is not intended for UK mediaHERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as ...

Boehringer Ingelheim Limited: FDA approves HERNEXEOS, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option

This press release is not intended for UK media HERNEXEOS (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as demonstrated in the Beamion LUNG-1 clinical trial1 Acceler ...