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Hernexeos FDA Approval History

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

FDA Approved: Yes (First approved August 8, 2025)
Brand name: Hernexeos
Generic name: zongertinib
Dosage form: Tablets
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Non Small Cell Lung Cancer

Hernexeos (zongertinib) is a kinase inhibitor used for the treatment of non-squamous non-small cell lung cancer (NSCLC) with HER2 (ERBB2) tyrosine kinase domain activating mutations.

Development timeline for Hernexeos

DateArticle
Aug  8, 2025Approval FDA Grants Accelerated Approval to Hernexeos (zongertinib) for Previously Treated Patients with HER2-Mutant Advanced NSCLC
Apr 28, 2025Boehringer’s New Zongertinib Data Demonstrates Durable and Clinically Meaningful Results in Patients with HER2 (ERBB2)-Mutant Advanced NSCLC
Feb 19, 2025Boehringer’s Zongertinib Receives Priority Review from U.S. FDA for the Treatment of HER2 (ERBB2)-Mutant Advanced Non-Small Cell Lung Cancer

Further information

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