Bizengri (Zenocutuzumab) Approved for NRG1 Fusion-Positive Cholangiocarcinoma Under the FDA’s National Priority Voucher Program by Madaline Spencer| Published on: May 13, 2026

https://checkrare.com/bizengri-zenocutuzumab-approved-for-nrg1-fusion-positive-cholangiocarcinoma-under-the-fdas-national-priority-voucher-program/ The US Food and Drug Administration (FDA) has approved Bizengri (zenocutuzumab) for the treatment of adults with NRG1 fusion-positive cholangiocarcinoma. Cholangiocarcinoma is a rare, aggressive cancer that forms in the bile duct. Patients with cholangiocarcinoma are often diagnosed at a later stage when the prognosis is poor. The disease can be classified based on whether the cancer is in the bile duct within the liver (intrahepatic cholangiocarcinoma [iCCA]) or outside the liver (extrahepatic cholangiocarcinoma). NRG1 gene fusions occur in less than 1% of cases and typically occur in patients who are otherwise driver negative, leaving affected patients without approved targeted therapy.