FDA expands sevabertinib approval in NSCLC
SOHO-01 data showed a 75% confirmed objective response rate among 69 patients without previous systemic therapy.
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By
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Kathryn Wighton
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September 9, 2026
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Clinical Scorecard: FDA expands sevabertinib approval in NSCLC
At a Glance
| Category | Detail |
|---|
| Condition | Locally advanced or metastatic nonsquamous non–small cell lung cancer |
| Key Mechanisms | Activating HER2 tyrosine kinase domain mutations |
| Target Population | Adult patients with specific HER2 mutations |
| Care Setting | Oncology |
Key Highlights
- Sevabertinib received accelerated approval for new indication.
- Efficacy evaluated in SOHO-01 trial with 75% objective response rate.
- Recommended dose is 20 mg orally twice daily with food.
- Warnings include diarrhea, hepatotoxicity, and interstitial lung disease.
- FDA review conducted under Project Orbis.
Guideline-Based Recommendations
Diagnosis
- HER2 tyrosine kinase domain mutations identified by FDA-authorized test.
Management
- Sevabertinib for patients with activating HER2 mutations.
Monitoring & Follow-up
- Monitor for response duration and adverse effects.
Risks
- Potential for diarrhea, hepatotoxicity, and other serious side effects.
Patient & Prescribing Data
Adult patients with locally advanced or metastatic nonsquamous NSCLC.
Efficacy demonstrated in patients with no prior systemic therapy.
Clinical Best Practices
- Confirm HER2 mutations in tumor tissue or plasma prior to treatment.
- Assess response using RECIST version 1.1.
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