Sevabertinib FDA Approval Status

Last updated by Judith Stewart, BPharm on June 10, 2025.

FDA Approved: No
Generic name: sevabertinib
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Non Small Cell Lung Cancer

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) in development for the treatment of HER2-mutant non-small cell lung cancer.

• Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for more than 85% of cases. Human epidermal growth factor receptor 2 (HER2) activating mutations are found in 2% to 4% of advanced NSCLC.
• Sevabertinib is a TKI that works in the treatment of HER2-mutant NSCLC by potently inhibiting mutant HER2, including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR.
• A New Drug Application (NDA) for sevabertinib has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced NSCLC whose tumors have activating HER2 mutations and who have received a prior systemic therapy. The NDA has been granted Priority Review designation.
• The NDA for sevabertinib was supported by positive results from the ongoing Phase I/II SOHO-01 trial in patients with advanced HER2-mutant NSCLC, which demonstrated an objective response rate of 70.5% in pre-treated patients, and a manageable safety profile consistent with previous reports.
• Sevabertinib is also being studied in patients with metastatic or unresectable solid tumors harboring HER2-activating mutations (panSOHO), excluding advanced NSCLC.

Development timeline for sevabertinib

Further information

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