Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that v::NRG1 status confers therapeutic sensitivity to Zenocutuzumab in patients with Cholangiocarcinoma.

The U.S. Food and Drug Administration granted approval to zenocutuzumab 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.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

Citation

Merus N.V. Bizengri (zenocutuzumab) [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 8, 2026. 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.

Contributions

Date	Contributor	Description
2026-10-08	Van Allen lab	Initial curation of this indication into moalmanac-db.
2026-05-08	Food and Drug Administration	Indication received traditional approval.