FDA Approves Bizengri (Zenocutuzumab) for NRG1 Fusion-Positive Cholangiocarcinoma, First Targeted Therapy for Ultra-Rare Bile Duct Cancer
The U.S. FDA approved Bizengri (zenocutuzumab-zbco) on May 8, 2026, for adults with advanced, unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma after prior systemic therapy.
This is the first FDA-approved therapy specifically for this ultra-rare, aggressive bile duct cancer, which affects fewer than 1% of cholangiocarcinoma cases.
Approval based on eNRGy trial (19 evaluable patients):
36.8% overall response rate, duration of response 2.8-12.9 months.
Expedited via Commissioner's National Priority Voucher (CNPV) awarded May 6, 2026, marking the seventh under the pilot program.
Previously approved in 2024 for NRG1+ NSCLC and pancreatic adenocarcinoma; developed by Merus, licensed to Partner Therapeutics in the US.
Cholangiocarcinoma has <15% 5-year survival; NRG1+ patients often lack targeted options.