1779.1 – Testing of tumour tissue to detect FGFR2 fusions or rearrangements in people with cholangiocarcinoma, to determine eligibility for treatment with PBS subsidised futibatinib

New MBS item (MSAC-PBAC co-dependent submission).

The test is to detect fusions or rearrangements in the FGFR2 gene in tumour tissue. Testing may be performed using next generation sequencing (NGS) or fluorescence in situ hybridisation (FISH). This test is for patients with locally advanced or metastatic cholangiocarcinoma and is used to determine eligibility for a potential new PBS subsidised treatment, futibatinib.

Type: Investigative technology

Cholangiocarcinoma is a rare type of cancer that develops in the bile ducts. The bile ducts are a group of thin tubes that carry bile (a digestive fluid) from the liver and gallbladder to the intestines.

The following consultation deadlines apply:

• Pre-PASC consultation deadline: Bypassing PASC
• Pre-MSAC consultation deadline: Friday 10 October 2025 11:59 pm AEDT  

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This application will be considered at the following meetings:

• PASC meeting: Bypassing PASC
• ESC meeting: Bypassing ESC
• MSAC meeting: 27 to 28 November 2025

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The outcome of this application is pending.

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