> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Boehringer Gets Breakthrough Status for Hernexeos
- URL: https://www.fdaweb.com/boehringer-gets-breakthrough-status-for-hernexeos/
- Published: 2025-09-03T12:00:00.000Z
- Updated: 2026-09-14T15:20:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159801

FDA has granted Boehringer Ingelheim a breakthrough therapy designation for Hernexeos (zongertinib) tablets for the first-line treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) mutations. The designation is supported by data from the ongoing Beamion-LUNG 1 trial, which is evaluating Hernexeos as an initial therapy in this patient population.

The agency granted Hernexeos accelerated approval earlier this year for previously treated patients with HER2-mutant advanced NSCLC, based on tumor response rates and duration of response. Boehringer says it will share updated Hernexeos clinical data at the World Conference on Lung Cancer later this month.

Hernexeos is described as a targeted, irreversible tyrosine kinase inhibitor that selectively blocks HER2 while sparing wild-type EGFR, which may help reduce side effects. The drug is also being studied across a range of solid tumors with HER2 alterations.