Zenocutuzumab
[3][4][5] It is the first approval by the US Food and Drug Administration (FDA) of a systemic therapy for people with non-small cell lung cancer or pancreatic adenocarcinoma harboring an neuregulin 1 gene fusion.[6] Zenocutuzumab is indicated for the treatment of adults with advanced, unresectable or metastatic non-small cell lung cancer harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy; adults with advanced, unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy.[1][3] The US Food and Drug Administration prescribing information for zenocutuzumab includes a boxed warning for embryo-fetal toxicity.[3] The trial enrolled 64 adults with advanced or metastatic neuregulin 1 gene fusion-positive non-small cell lung cancer and 30 adults with advanced or metastatic neuregulin 1 gene fusion-positive pancreatic adenocarcinoma who had disease progression following standard of care treatment.[3] Identification of positive neuregulin 1 gene fusion status was prospectively determined by next generation sequencing assays.