FDA Grants Accelerated Approval to Bayer’s HYRNUO for Advanced HER2-Mutant Lung Cancer
The FDA has granted accelerated approval to Bayer's HYRNUO™ (sevabertinib) for treating advanced HER2-mutant lung cancer. This approval is for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations, who have previously received systemic therapy. Sevabertinib is a tyrosine kinase inhibitor, and the approval follows Priority Review and Breakthrough Therapy Designation. Bayer AG announced this on November 20, 2025.
Bayer AG has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for HYRNUO™ (sevabertinib) for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have previously received systemic therapy. Sevabertinib is an oral, reversible small molecule tyrosine kinase inhibitor. The approval follows Priority Review and Breakthrough Therapy Designation. Additionally, sevabertinib received Breakthrough Therapy designation from both the FDA and the Chinese CDE in 2024, and a new drug application was accepted in China in July 2025. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Bayer AG published the original content used to generate this news brief on November 20, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
