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The FDA approved zenocutuzumab-zbco on 8 May for adults with advanced, unresectable or metastatic cholangiocarcinoma harbouring an NRG1 gene fusion.
The indication covers disease progression on or after prior systemic therapy. FDA describes NRG1-fusion positive cholangiocarcinoma as extremely rare and life-threatening.
FDA says safety and efficacy were evaluated in the eNRGy multicohort trial, including patients with unresectable or metastatic NRG1 fusion-positive cholangiocarcinoma.
Sourcing note: Indication, biomarker language and trial framing are from FDA. This article does not compare treatment options.
Why It Matters
Rare cancer approvals show the narrowing of oncology into smaller molecular subgroups. That can create targeted options, but also makes testing and patient identification central to care.
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