ACTARIN (Actor Pharmaceuticals Pty Ltd)
Product name
ACTARIN
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
151 (255 working days)
Active ingredients
midostaurin
Registration type
New generic medicine
Indication
[TRADE NAME] is indicated:
- in combination with standard anthracycline and cytarabine induction and cytarabine consolidation chemotherapy, followed in patients in complete response by single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive
- for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasms (SM-AHN), or mast cell leukaemia (MCL).