IVOSIDENIB

Information current as at: 1 July 2026

PBAC meeting date: November 2026
Legend: Completed N In progress Not applicable N Yet to commence

Submission Details

Brand name:
  • Tibsovo®
Form and strength:
  • Tablet 250 mg
Submission sponsor:
SERVIER LABORATORIES (AUST.) PTY. LTD.
Condition/indication:
(therapeutic use)
  • Acute myeloid leukaemia (AML)
Listing requested:
To request listing of ivosidenib for the treatment of patients with newly diagnosed, isocitrate dehydrogenase-1 (IDH1) mutation positive AML who are not eligible to receive intensive induction chemotherapy.
Funding program:
PBS General Schedule
Request authority level:
Authority Required (STREAMLINED)
PBAC Submission type:
Change to existing listing (–)
Comment:
--
Other PBAC consideration:
--

Progress Details

Submission received for:
November 2026 PBAC meeting
2Opportunity for consumer comment:
Open 22/07/2026 and close 16/09/2026 (see PBS Website)
3PBAC meeting:
Has not yet occurred
4PBAC outcome published:
Pending PBAC outcome (see PBAC Outcomes)
5Lodgement of required documentation:
6Agreement to listing arrangements:
Has not yet commenced
7Government processes:
Has not yet commenced
8Medicine listed on the PBS:
Has not yet occurred
Glossary

PBAC Outcome

PBAC Recommendation:
Please see the Outcomes from the relevant meeting for more information
Case ID
a1290
Page last updated
23 July 2026
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