On August 8 th 2025, the FDA announced accelerated approval for a new small molecule aimed at treating unresectable or metastatic non-squamous Non-small cell lung cancer (NSCLC) with HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. Breakthrough designation was awarded after reaching the primary and secondary safety and efficacy endpoints. Supporting data was reported in New England Medical Journal  in April 2025.   Drug Info: Name(s): zongertinib, BI 1810631,