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# Partner Therapeutics Wins Approval for Bile Duct Cancer Therapy
- URL: https://www.fdaweb.com/partner-therapeutics-wins-approval-for-bile-duct-cancer-therapy/
- Published: 2026-05-08T12:00:00.000Z
- Updated: 2026-09-14T13:38:54.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161118

FDA has approved a Partner Therapeutics BLA for Bizengri (zenocutuzumab-zbco) for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion whose disease has progressed following prior systemic therapy. The monoclonal antibody is designed to target the extremely rare and aggressive form of bile duct cancer driven by NRG1 gene fusions.

The approval was granted under the agency’s National Priority Review Voucher (CNPV) pilot program, an initiative launched by FDA commissioner **Marty Makary** to accelerate reviews for products addressing major national health priorities.

According to FDA, the BLA was approved more than five months ahead of the agency’s target review deadline. The application also received priority review, breakthrough therapy designation, and orphan drug designation.

The approval action was based on results from the Phase 1/2 eNRGy trial, an open-label, multicenter study evaluating the drug in patients with advanced solid tumors harboring NRG1 fusions. Among 22 patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma enrolled in the study, 19 were evaluable for efficacy. FDA said the confirmed overall response rate was 36.8%, with responses lasting between 2.8 months and 12.9 months, as assessed by blinded independent central review using RECIST v1.1 criteria.

The therapy’s prescribing information includes warnings for infusion-related reactions, hypersensitivity and anaphylaxis, interstitial lung disease and pneumonitis, left ventricular dysfunction, and embryo-fetal toxicity, FDA said. The most common adverse events reported in clinical testing included diarrhea, musculoskeletal pain, fatigue, nausea, infusion-related reactions, dyspnea, rash, constipation, vomiting, abdominal pain, and edema.