FDA grants HERNEXEOS® Breakthrough Therapy Designation for first-line treatment in HER2-mutant advanced NSCLC
Thursday, September 04, 2025
Boehringer Ingelheim has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to HERNEXEOS® (zongertinib tablets) for the first-line treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) carrying HER2 (ERBB2) tyrosine kinase domain activating mutations.
The designation is intended to speed up the development and review of medicines for serious diseases, where early clinical evidence shows potential for significant improvement over existing treatments.
HERNEXEOS recently received FDA accelerated approval for adults with unresectable or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations, following prior systemic therapy. The approval was based on objective response rate and duration of response, with continued approval dependent on confirmation of clinical benefit in further studies.
Boehringer Ingelheim plans to share additional data on HERNEXEOS at the World Conference on Lung Cancer (WCLC) in September and the European Society for Medical Oncology (ESMO) congress in October.
Source: prnewswire.com
