FUTIBATINIB
Information current as at: 1 August 2026
Submission Details
- Brand name:
-
- Lytgobi®
- Form and strength:
-
Tablet 4 mg
- Submission sponsor:
- TAIHO PHARMA OCEANIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Bile duct cancer
- Listing requested:
- Resubmission to request listing of futibatinib for the treatment of patients with locally advanced or metastatic cholangiocarcinoma who have previously progressed on systemic therapy and have a fibroblast growth factor receptor 2 fusion or rearrangement.
- Funding program:
- Please see meeting agenda for more information
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- New listing (–)
- Comment:
- To be considered prior to the March 2026 PBAC meeting.
- Other PBAC consideration:
Progress Details
-
Submission received for: - March 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 30/07/2025 and close 24/09/2025 (see PBS Website)
-
PBAC meeting: - Held on 11/03/2026
-
Lodgement of required documentation: - 13/02/2026
-
Acceptance of complete documentation:
- Accepted
-
Agreement to listing arrangements: - Commenced on 24/03/2026
-
Status:
- Finalised
-
Government processes: - Commenced on 08/04/2026
-
Medicine listed on the PBS: - 01/07/2026 (see PBS schedule)
PBAC Outcome
The PBAC recommended the PBS listing of futibatinib for the treatment of patients with locally advanced or metastatic cholangiocarcinoma (a type of cancer in the bile duct) which has grown or spread despite being treated previously and has a specific genetic change; the fibroblast growth factor receptor 2 (FGFR2) genetic variant in tumour tissue. The PBAC noted that Medical Benefits Scheme funding for testing for the FGFR2 variant in cancer tissue has now been supported by the Medical Services Advisory Committee.