Partner Therapeutics has submitted a supplemental application to the U.S. Food and Drug Administration seeking approval of zenocutuzumab-zbco for adults with advanced or metastatic cholangiocarcinoma carrying NRG1 gene fusions. The National Comprehensive Cancer Network has already added the drug to its guidelines as a recommended option in biliary tract cancers.
The submission is supported by the phase 1/2 eNRGy trial. In patients with cholangiocarcinoma, the overall response rate was 36.8%, and responses lasted a median of 12.9 months. The treatment was well tolerated, with no discontinuations due to adverse effects, suggesting a favorable safety profile.
Zenocutuzumab targets tumors driven by rare NRG1 gene fusions, making accurate identification essential. Experts highlight the importance of RNA-based tumor testing to find eligible patients. The international eNRGy study included multiple tumor types, with patients receiving intravenous treatment every two weeks.