Posted by Michael Wonder on 04 Sep 2025
FDA grants Hernexeos breakthrough therapy designation for first-line use in HER2 mutant advanced NSCLC
3 September 2025 - Breakthrough therapy designation is based on results from the Beamion-LUNG 1 clinical trial evaluating Hernexeos (zongertinib tablets) as a first-line treatment in HER2 mutant advanced non-small cell lung cancer.
Boehringer Ingelheim today announced Hernexeos (zongertinib tablets) has been granted breakthrough therapy designation by the US FDA for first-line treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer whose tumours have HER2 (ERBB2) tyrosine kinase domain activating mutations.
