Biotechnology company Partner Therapeutics Inc (PTx) announced on Wednesday that the US Food and Drug Administration (FDA) has awarded a Commissioner's National Priority Voucher (CNPV) pilot program voucher for BIZENGRI (zenocutuzumab-zbco) for the treatment of adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.

PTx submitted a supplemental Biologics License Application (sBLA) 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.

The FDA's Commissioner's National Priority Voucher pilot program, announced in June 2025, is designed to reduce drug and biologic review times from the standard 10–12 months to as little as 1–2 months for products that align with one or more US national health priorities. These priorities focus on advancing innovative breakthrough therapies that introduce novel mechanisms and meaningfully improve how diseases are treated, while also addressing significant unmet medical needs where current treatment options fall short for patients.

Data from the cohort of patients with NRG1+ cholangiocarcinoma in the Phase 2 eNRGy trial were presented at the AACR-NCI-EORTC Meeting in October 2025, highlighting clinical outcomes in this rare cancer.