Posted by Michael Wonder on 07 May 2026
Partner Therapeutics announces receipt of FDA Commissioner's National Priority Voucher for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
6 May 2026 - Partner Therapeutics today announced that the US FDA has awarded a Commissioner's National Priority Voucher pilot program voucher for Bizengri (zenocutuzumab-zbco) 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.
Partner Therapeutics submitted a supplemental biologics license application to the FDA for this indication based on data from the Phase 2 eNRGy trial.
Bizengri previously received breakthrough therapy designation and orphan drug designation from the FDA for NRG1+ cholangiocarcinoma.
