Zongertinib (Hernexeos) for NSCLC

Zongertinib (Hernexeos – Boehringer Ingelheim), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of adults with unresectable or metastatic nonsquamous non-small cell lung cancer (NSCLC) with human epidermal growth factor 2 (HER2) tyrosine kinase domain activating mutations who had received prior systemic therapy. It is the first oral targeted therapy to be approved in the US for this indication. The intravenous HER2-directed antibody and topoisomerase inhibitor conjugate famtrastuzumab deruxtecan (Enhertu) was approved for the same indication in 2022.