FDA Grants Accelerated Approval to Sevabertinib for HER2-Mutant Lung Cancer

ContributorsProf. Dr. Mustafa ÖzdoğanAuthor · Medical review · Editorial approval

PublishedNov 22, 2025

UpdatedOct 17, 2026

2 min read

FDA Grants Accelerated Approval to Sevabertinib for HER2-Mutant Lung Cancer

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Accelerated Approval • Lung Cancer • 19 November 2025

A New Pill for HER2-Mutant Lung Cancer: Sevabertinib

For previously chemotherapy-treated patients with HER2-mutant non-small cell lung cancer (NSCLC), the FDA approved the oral kinase inhibitor Sevabertinib (Hyrnuo) . Response rates in patients without previous targeted treatment reached 71% .

📚 Source: FDA & SOHO-01 Trial

On 19 November 2025, the US Food and Drug Administration (FDA) granted, for adults whose tumors carry HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations and who have previously systemically treated, locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC), the kinase inhibitor sevabertinib (Hyrnuo, Bayer HealthCare Pharmaceuticals Inc.) accelerated approval.

The FDA also approved, as a companion diagnostic to identify patients eligible for this treatment, the Oncomine Dx Target Test.

Target: HER2 Mutation

HER2 mutations in lung cancer are rare (approximately 2–4% of patients) but follow an aggressive course. Until now, ‘antibody–drug conjugates’ (intravenously administered targeted chemotherapies) have been prominent in this field.

Sevabertinibis an oral drug that blocks the intracellular signaling pathway: a Tyrosine Kinase Inhibitor (TKI). For patients, this means the possibility of treatment at home without hospitalization.

🔍 Study: SOHO-01

Approval is based on SOHO-01 (NCT05099172) , a multicenter, open-label study.

Patients were examined in two different groups according to their previous treatments. This distinction is critical for understanding the drug’s efficacy.

SOHO-01 Efficacy Data

GROUP A: Patients WITHOUT Previous HER2-Targeted Treatment

71%

Objective Response Rate (ORR)

Median Duration of Response: 9.2 Months
(Response lasted longer than 6 months in 54% of patients)

GROUP B: Patients WITH Previous HER2 ADC Treatment (e.g., Enhertu)

38%

Objective Response Rate (ORR)

Median Duration of Response: 7.0 Months
(Response lasted longer than 6 months in 60% of patients)

💡 Clinical Meaning: These results show that Sevabertinib is effective both as a first-line targeted treatment (71% success in Group A) and as a salvage treatment after resistance to other potent drugs (ADCs) develops (38% success in Group B).

Administration and Safety

💊 Recommended Dosage

20 mg (Orally, twice daily)
*Must be taken with food.

⚠️ Adverse-Effect Warnings

Adverse effects characteristic of tyrosine kinase inhibitors may occur:

Diarrhea
Interstitial Lung Disease (ILD/Pneumonitis)
Ocular Toxicity
Hepatotoxicity (Elevated liver enzymes)

Sources:

FDA. FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer. 19 November 2025. [FDA Announcement]
ClinicalTrials.gov. A Study of Sevabertinib in HER2 Mutated NSCLC (SOHO-01). NCT05099172. [Clinical Trial Details]

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FDA Grants Accelerated Approval to Sevabertinib for HER2-Mutant Lung Cancer

A New Pill for HER2-Mutant Lung Cancer: Sevabertinib