Bizengri becomes first approved drug for advanced NRG1 fusion-positive cholangiocarcinoma
Updated
Updated · FDA.gov · May 9
Bizengri becomes first approved drug for advanced NRG1 fusion-positive cholangiocarcinoma
11 articles · Updated · FDA.gov · May 9
The US FDA cleared the treatment for adults with unresectable or metastatic disease after prior systemic therapy, granting approval to Partner Therapeutics under its seventh National Priority Voucher review.
In a single-arm trial of 19 patients, 36.8% had an overall response, with responses lasting 2.8 to 12.9 months.
Bizengri previously won accelerated approval in 2024 for NRG1 fusion-positive lung and pancreatic cancers; serious risks include infusion reactions, pneumonitis and left ventricular dysfunction.
Is the FDA's new fast-track voucher a lifeline for rare disease patients or a high-stakes gamble for drug companies?
Will the FDA’s controversial fast-track program, criticized for secrecy, survive its upcoming public review and internal turmoil?
Landmark FDA Approval of Bizengri (Zenocutuzumab) for NRG1 Fusion-Positive Cholangiocarcinoma: Precision Oncology Breakthrough in Rare Bile Duct Cancer
Overview
On May 8, 2026, the FDA approved Bizengri (zenocutuzumab-zbco) as the first targeted therapy for adults with advanced, unresectable, or metastatic cholangiocarcinoma driven by NRG1 gene fusions, especially for those whose disease progressed after prior treatment. This approval was granted over five months ahead of schedule, thanks to the FDA Commissioner’s National Priority Review Voucher pilot program, which expedited the review process. The decision was based on strong results from the eNRGy clinical trial, showing Bizengri’s effectiveness and addressing a major unmet need for patients with this rare and aggressive cancer.