FDA expands Bizengri to NRG1 fusion-positive cholangiocarcinoma

Partner Therapeutics said the US Food and Drug Administration has approved Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring an NRG1 gene fusion after prior systemic therapy. The approval, announced May 8 and publicized by the company May 11, 2026, expands Bizengri beyond its December 2024 accelerated approvals in NRG1 fusion-positive non-small cell lung cancer and pancreatic adenocarcinoma. FDA said the decision was supported by data from the phase 2 eNRGy trial, in which 22 patients with NRG1 fusion-positive cholangiocarcinoma were enrolled and 19 were evaluable for efficacy. (fda.gov)

Why it matters: For veterinary professionals tracking precision oncology, this is another example of how ultra-rare, biomarker-defined cancers are reshaping treatment pathways. The cholangiocarcinoma cohort showed an overall response rate of 36.8%, and Partner Therapeutics has emphasized that tissue-based RNA testing is important because standard DNA-based panels can miss NRG1 fusions. That’s a useful signal for oncology teams watching how companion diagnostics, referral workflows, and targeted therapy access may evolve across species, even though Bizengri is a human oncology drug. (partnertx.com)

What to watch: Watch for label publication in Drugs@FDA, payer and guideline uptake, and whether confirmatory or broader tumor-agnostic development follows. (fda.gov)