Zenocutuzumab
Zenocutuzumab, sold under the brand name Bizengri, is a humanized monoclonal antibody used for the treatment of non-small cell lung cancer or pancreatic cancer. It is a low-fucose humanized full-length immunoglobulin G1 bispecific HER2- and HER3-directed antibody.
The most common adverse reactions include diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema. The most common grade 3 or 4 laboratory abnormalities include increased gamma-glutamyl transferase, decreased hemoglobin, decreased sodium, and decreased platelets.
Zenocutuzumab was approved for medical use in the United States in December 2024. It is the first approval by the US Food and Drug Administration of a systemic therapy for people with non-small cell lung cancer or pancreatic adenocarcinoma harboring an neuregulin1 gene fusion. The FDA considers it to be a first-in-class medication.
Medical uses
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.Adverse effects
The US Food and Drug Administration prescribing information for zenocutuzumab includes a boxed warning for embryo-fetal toxicity.History
Efficacy was evaluated in the eNRGy study, a multicenter, open-label, multicohort trial. 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. Identification of positive neuregulin 1 gene fusion status was prospectively determined by next generation sequencing assays.The US Food and Drug Administration granted the application for Zenocutuzumab priority review, breakthrough therapy, and orphan drug designations.