Zenocutuzumab: First Approval

Zenocutuzumab (zenocutuzumab-zbco; BIZENGRI^®), an IgG1 bispecific human epidermal growth factor receptor (HER)2- and HER3-directed antibody, is being developed by Merus for the treatment of solid tumours with neuregulin 1 (NRG1) gene fusions. On 4 December 2024, zenocutuzumab received its first approval in the USA for the treatment of adults with advanced, unresectable or metastatic pancreatic adenocarcinoma or non-small cell lung cancer (NSCLC) harbouring an NRG1 gene fusion with disease progression on or after prior systemic therapy. This article summarizes the milestones in the development of zenocutuzumab leading to this first approval for the second-line treatment of NRG1+ pancreatic adenocarcinoma or NSCLC.