FDA approves zenocutuzumab-zbco for advanced, unresectable or metastatic cholangiocarcinoma
On May 8, 2026, the FDA approved zenocutuzumab-zbco (Bizengri) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring an NRG1 gene fusion with disease progression on or after prior systemic therapy. Approval was supported by the open-label eNRGy trial, in which 19 patients were evaluable for efficacy; confirmed ORR was 36.8% (95% CI 16.3–61.6) and DOR ranged from 2.8 to 12.9 months. Key labeled safety risks include IRR/hypersensitivity/anaphylaxis, ILD/pneumonitis, and left ventricular dysfunction.
FDA regulatory approval (May 8, 2026)
The FDA approved zenocutuzumab-zbco (Bizengri; Partner Therapeutics, Inc.) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion, with disease progression on or after prior systemic therapy.
The application was reviewed under the FDA Commissioner’s National Priority Review Voucher (CNPV) pilot program, received priority review, and had breakthrough therapy and orphan drug designations. FDA reported approving the application over 5 months ahead of the goal date.
Supporting evidence
Efficacy and safety were evaluated in eNRGy (NCT02912949), a multicenter, open-label, multi-cohort trial in adults with advanced solid tumors. In the cholangiocarcinoma cohort, 22 patients with unresectable/metastatic NRG1 fusion–positive disease were enrolled; 19 were evaluable for efficacy.
Primary efficacy outcomes were confirmed ORR and DOR by blinded independent central review (RECIST v1.1):
- ORR: 36.8% (95% CI, 16.3–61.6)
- DOR: 2.8 to 12.9 months
Label highlights
Warnings/precautions include infusion-related reactions/hypersensitivity/anaphylaxis, ILD/pneumonitis, left ventricular dysfunction, and embryo-fetal toxicity. Recommended dose: 750 mg IV every 2 weeks until progression or unacceptable toxicity.
Full prescribing information is expected to be posted on Drugs@FDA.