Zenocutuzumab (MCLA-128) is being developed for the potential treatment of NRG1 fusion (NRG1+) lung, pancreas and other cancers, including cholangiocarcinoma (CCA). The eNRGy trial, a phase 1/2 clinical trial is an ongoing open-label, multicenter trial that enrolled patients with NRG1+ solid tumors. In December 2024, the FDA granted accelerated approval for zenocutuzumab for the treatment of adults with advanced, unresectable or metastatic non-small cell lung or pancreatic cancer harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Most recently, in May, 2026, approval was also granted for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
