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# Commissioner’s National Priority Voucher for Bizengri
- URL: https://www.fdaweb.com/commissioners-national-priority-voucher-for-bizengri/
- Published: 2026-05-06T12:00:00.000Z
- Updated: 2026-09-14T13:38:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161101

FDA has awarded a Commissioner’s National Priority Voucher to Partner Therapeutics for its Bizengri (zenocutuzumab-sbco) to treat adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior therapy. A company [statement](https://www.prnewswire.com/news-releases/partner-therapeutics-announces-receipt-of-fda-commissioners-national-priority-voucher-for-bizengri-zenocutuzumab-zbco-in-nrg1-fusion-positive-cholangiocarcinoma-302764204.html?ref=fdaweb.com) says it submitted a BLA to FDA for the indication based on data from the Phase 2 eNRGy trial. The drug previously received breakthrough therapy designation and orphan drug designation from FDA for the indication.

Bizengri is already indicated to treat adults with advanced unresectable or metastatic non-small cell lung cancer harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy. It is also indicated to treat adults with advanced unresectable or metastatic pancreatic adenocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy. Both indications received accelerated approval from FDA based on overall response rate and duration of response.