Bizengri (zenocutuzumab-zbco) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Merus N.V. Bizengri (zenocutuzumab-zbco) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761352s010lbl.pdf. Revised May 2026. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
BIZENGRI is a bispecific HER2- and HER3-directed antibody indicated 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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	v::NRG1	Cholangiocarcinoma	Zenocutuzumab