FDA Approves Zenocutuzumab (Bizengri) for NRG1 Fusion-Positive Bile Duct Cancer — First Targeted Therapy for This Oncogenic Driver

The FDA granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus NV/Partner Therapeutics) for adults with advanced, unresectable or metastatic cholangiocarcinoma (bile duct cancer) harboring an NRG1 gene fusion, after prior systemic therapy. The approval was based on efficacy data from the eNRGy basket trial (NCT02912949), with 19 evaluable patients with NRG1 fusion-positive cholangiocarcinoma demonstrating objective responses to Bizengri. Zenocutuzumab is a bispecific antibody (biclonics) targeting both HER2 and HER3, blocking oncogenic NRG1 ligand-receptor signaling that drives NRG1 fusion-positive cancers. NRG1 fusions occur in approximately 1-3% of multiple solid tumors and represent an increasingly recognizable oncogenic driver class amenable to targeted therapy. This is the first FDA-approved therapy specifically indicated for NRG1 fusion-positive cholangiocarcinoma, and extends Bizengri's prior approvals in NRG1+ non-small cell lung cancer and pancreatic cancer. The approval was granted over 5 months ahead of the PDUFA goal date under Priority Review. Bile duct cancer (cholangiocarcinoma) typically carries a poor prognosis with limited effective treatments after first-line chemotherapy.