Posted by Michael Wonder on 15 Apr 2026
Partner Therapeutics announces submission of supplemental biologics license application to FDA for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma
14 April 2026 - Partner Therapeutics announces the submission of a supplemental biologics license application to the US FDA for Bizengri (zenocutuzumab-zbco), seeking approval for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion.
The supplemental biologics license application is supported by data from the eNRGy study evaluating zenocutuzumab-zbco in patients with NRG1 fusion positive cancers, including cholangiocarcinoma. In the cholangiocarcinoma cohort, BIZENGRI demonstrated an overall response rate of 36.8% (95%CI: 16.3, 61.6%) and a median duration of response of 12.9 months, as assessed by blinded independent central review.
