Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team

- 2 days ago
- 1 min read
05/02/2026
Partner Therapeutics' zenocutuzumab received the FDA orphan drug designation for cholangiocarcinoma (Ref)
The US FDA granted the orphan drug designation to Partner Therapeutics' zenocutuzumab‑zbco (HER2xHER3 bispecific antibody) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma.
Zenocutuzumab is being developed in a subset of patients with cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion
Juan W. Valle, MD, CMO, Cholangiocarcinoma Foundation: “Patients with cholangiocarcinoma face a particularly aggressive cancer with poor prognosis and limited treatment options. Receiving Orphan Drug Designation for zenocutuzumab in patients with CCA harboring the NRG1 gene fusion is a significant regulatory milestone for Partner Therapeutics and highlights the urgent need for new and effective treatment options for patients with this disease.”
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