Clinical Report: FDA expands sevabertinib approval in NSCLC

Overview

The FDA has granted accelerated approval for sevabertinib to treat adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) harboring activating HER2 mutations.

Background

Sevabertinib is a kinase inhibitor that targets HER2 mutations, which are present in a subset of NSCLC patients.

Data Highlights

Key Findings

• The FDA granted accelerated approval for sevabertinib for treatment-naive patients with HER2-mutant NSCLC.
• In the SOHO-01 trial, the objective response rate was 75% among treatment-naive patients.
• 73% of responding patients maintained a response for at least 6 months.
• 38% of responding patients had a response lasting at least 12 months.
• The recommended dose of sevabertinib is 20 mg orally twice daily with food.

Clinical Implications

Monitoring for potential side effects, including diarrhea and hepatotoxicity, is essential during treatment.

Conclusion

The expanded approval of sevabertinib is for patients with HER2-mutant NSCLC.

Related Resources & Content

1. US Food and Drug Administration, FDA, 2026 -- FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
2. The ASCO Post, 2025 -- Research Supports FDA Approval of Sevabertinib for HER2-Mutant Lung Cancer
3. The ASCO Post, 2025 -- FDA Grants Accelerated Approval to Sevabertinib for Nonsquamous NSCLC
4. The ASCO Post, 2025 -- Reversible TKI in HER2-Mutant NSCLC
5. The ASCO Post, 2026 -- FDA Grants Accelerated Approval to Sevabertinib for Locally Advanced or Metastatic Nonsquamous Disease
6. the asco post — FDA Grants Accelerated Approval to Sevabertinib for Nonsquamous NSCLC
7. the asco post — FDA Approves Lazertinib With Amivantamab-vmjw for EGFR-Mutated NSCLC
8. NSCLC FDA Grants Accelerated Approval to Sevabertinib for Locally Advanced or Metastatic Nonsquamous Disease - The ASCO Post
9. FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer | FDA
10. Therapy for Stage IV Non–Small Cell Lung Cancer With Driver Alterations: ASCO Living Guideline, Version 2026.3.2