Posted by Michael Wonder on 23 Oct 2025
Zenocutuzumab-zbco granted FDA breakthrough therapy designation for NRG1 positive cholangiocarcinoma
23 October 2025 - Partner Therapeutics today announced that the US FDA has granted breakthrough therapy designation to zenocutuzumab-zbco for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harbouring a neuregulin 1 (NRG1) gene fusion.
The designation was supported by results from the ongoing investigational Phase 2 eNRGy trial.
