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.