We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
TIBSOVO (Servier Laboratories (Aust) Pty Ltd)
Product name
TIBSOVO
Date registered
Evaluation commenced
Decision date
Approval time
215 (255 working days
Active ingredients
ivosidenib
Registration type
NCE/NBE
Indication
Acute myeloid leukaemia
TIBSOVO is indicated for the treatment of acute myeloid leukaemia (AML) that carries an IDH1 R132 mutation:
- as monotherapy, or in combination with azacitidine, in newly diagnosed patients who are not eligible to receive intensive induction chemotherapy; or
- as monotherapy in patients whose AML is relapsed and/or refractory to prior therapy.