2025 Approvals

HERNEXEOS® (zongertinib) Tablets: A New Treatment for HER2-Mutated NSCLC Approved by the FDA on August 8, 2025

Heather Mantica

06 Nov 2025 — 1 min read

ChatGPT Image Nov 6, 2025, 01_53_18 PM

What is it prescribed for?

HERNEXEOS is used in adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has a HER2 mutation and has already been treated with another systemic therapy.

What is the name of the drug and what does it do?

The medicine is HERNEXEOS® (zongertinib). It is a medicine in pill form that you take once a day. It works by blocking a special signal in the body called HER2 that makes some cancer cells grow too fast.

How does it work?

The drug blocks abnormal HER2 signaling, which drives the growth of cancer cells. By blocking this signal, the medicine can slow down or even shrink certain types of tumors (lumps made of cancer cells) that have this HER2 change (mutation). it’s a daily pill that helps stop HER2-mutated cancer cells from growing.

What did the research discover?

In clinical studies, many patients had meaningful tumor shrinkage and disease control. Some responses lasted several months or longer.

What are some of the side effects?

Common: diarrhea, rash, fatigue, nausea
Laboratory changes: higher liver enzymes, electrolyte changes
Serious: liver injury, heart problems, and lung inflammation

What are the dosage recommendations and how is it prescribed?

The dose is based on weight:

120 mg daily if under 90 kg
180 mg daily if 90 kg or more
Treatment continues until cancer worsens or side effects become too severe. Doctors closely monitor liver function, heart health, and lungs.

Source:

HERNEXEOS® (zongertinib) tablets, for oral use [prescribing information]. Ridgefield (CT): Boehringer Ingelheim Pharmaceuticals, Inc.; 2025 Aug. Accessed by: http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219042s000lbl.pdf

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