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FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

The decision uses limited single-arm trial data to address a severe lack of options.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Overview

  • The FDA cleared zenocutuzumab-zbco for adults with advanced, unresectable, or metastatic cholangiocarcinoma that carries NRG1 fusions after prior systemic therapy.
  • The approval rests on the eNRGy study, where 19 evaluable patients showed a 36.8% overall response and responses lasted 2.8 to 12.9 months.
  • The review moved through the National Priority Voucher pilot program, marking the seventh approval granted under this faster pathway.
  • The label flags serious risks that include infusion reactions, interstitial lung disease or pneumonitis, and reduced heart pumping called left ventricular dysfunction.
  • The decision is likely to drive broader testing for NRG1 fusions, and the drug now appears in NCCN biliary guidelines as a recommended option after earlier treatment.