Biotechnology company Partner Therapeutics Inc (PTx) announced on Thursday that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to zenocutuzumab-zbco for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma.

Cholangiocarcinoma (CCA) is a rare, aggressive malignancy of the bile ducts, typically diagnosed at an advanced stage when curative options are limited.

Zenocutuzumab-zbco is being developed in a subset of patients with CCA harboring a neuregulin 1 (NRG1) gene fusion. It has shown activity in patients with cholangiocarcinoma harbouring NRG1 gene fusion.

Zenocutuzumab-zbco, marketed as BIZENGRI, received Breakthrough Therapy Designation from the FDA in October 2025 and was granted accelerated approval in December 2024 for adults with advanced unresectable or metastatic non-small cell lung cancer and pancreatic ductal adenocarcinoma harbouring NRG1 gene fusions following prior therapy.