FDA Grants Seventh National Priority Voucher Approval for Bizengri in Rare NRG1 Fusion Cholangiocarcinoma

FDA approved Bizengri (zenocutuzumab-zbco) for adults with unresectable or metastatic NRG1 fusion–positive cholangiocarcinoma, the seventh approval under the Commissioner’s National Priority Voucher program. Efficacy comes from a 19-patient single-arm trial showing a 36.8% overall response; safety concerns include infusion-related reactions, interstitial lung disease/pneumonitis, and cardiac effects, with Breakthrough Therapy and Orphan Drug designations previously granted. A June 4, 2026 public meeting will discuss CNPV program details, with written comments due by June 29, 2026.