What Was Approved?
On November 19, 2025, the U.S. Food and Drug Administration granted accelerated approval to Hyrnuo (sevabertinib) for adults with locally advanced or metastatic non-squamous non-small cell lung cancer, or NSCLC, whose tumors have specific HER2 (ERBB2) tyrosine kinase domain activating mutations.
Patients must also have received a prior systemic therapy.
An FDA-approved test is required to identify the relevant HER2 mutation.
How Does Hyrnuo Work?
Hyrnuo is a kinase inhibitor designed to target abnormal HER2 signaling that can promote cancer-cell growth in certain tumors.
It is not intended for every patient with lung cancer or every type of HER2 alteration.
How Is Hyrnuo Taken?
The recommended dose is:
20 mg by mouth twice daily with food.
The tablets should be swallowed whole and should not be cut, crushed, or chewed.
Treatment is generally continued until disease progression or unacceptable toxicity.
Why Was It Granted Accelerated Approval?
Hyrnuo received accelerated approval based on objective response rate and duration of response in the SOHO-01 clinical trial.
Because this was an accelerated approval, continued approval may depend on a confirmatory study showing clinical benefit.
What Are Common Side Effects?
In the safety population, common adverse reactions included:
- Diarrhea
- Rash
- Paronychia
- Stomatitis
- Nausea
- Dry skin
- Decreased appetite
- Weight loss
- Fatigue
Diarrhea was especially common and could be severe in some patients.
Bottom Line
Hyrnuo (sevabertinib) is an FDA-approved oral targeted therapy for certain adults with previously treated, locally advanced or metastatic non-squamous NSCLC whose tumors have qualifying HER2 (ERBB2) activating mutations.
Because the approval was accelerated and treatment eligibility depends on specific biomarker testing, therapy should be guided by an oncology team.
Sources
- U.S. Food and Drug Administration (FDA) — FDA Grants Accelerated Approval to Sevabertinib for Non-Squamous Non-Small Cell Lung Cancer, November 19, 2025.
- U.S. Food and Drug Administration (FDA) — Drug Trials Snapshot: Hyrnuo.
- U.S. Food and Drug Administration (FDA) — Hyrnuo (sevabertinib) Prescribing Information, 2025.
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2025.