> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Breakthrough for NRG1+ Cholangiocarcinoma Drug
- URL: https://www.fdaweb.com/fda-breakthrough-for-nrg1-cholangiocarcinoma-drug/
- Published: 2025-10-24T12:00:00.000Z
- Updated: 2026-09-14T15:24:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160104

FDA has granted Partner Therapeutics a breakthrough therapy designation for zenocutuzumab-zbco and its use for treating cholangiocarcinoma defined by NRG1 gene fusions. The designation covers adults with advanced unresectable or metastatic NRG1+ cholangiocarcinoma, the company says, and is based on data from the Phase 2 eNRGy trial. The company says NRG1 fusions are a rare but increasingly recognized target as RNA-based next-generation sequencing proliferates in clinical practice.

Partner says a recent interim readout of the trial found:

• 37% overall response rate  
• 7.4 months median duration of response  
• 1.9 months median time to response  
• 9.2 months median progression-free survival  
• 58% clinical benefit rate (responses or durable stable disease)

PTx plans to leverage those results for a supplemental BLA filing in 2026\. Zenocutuzumab-zbco (Bizengri) currently has accelerated approval for NRG1-positive non-small cell lung cancer and pancreatic cancer after prior therapy.