COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF MIDOSTAURIN (RYDAPT) AS AN ORPHAN DRUG
I, Dr Anthony Gill, Delegate of the Secretary for the purposes of 16J of the Therapeutic Goods Regulations 1990 (“the Regulations”), acting under subregulation 16J(2) of the Regulations, designate midostaurin (RYDAPT) as an orphan drug on 22 June 2016 for the treatment of adult patients with the following:
- Newly diagnosed acute myeloid leukaemia (AML) who are Fms-like Tyrosine Kinase 3 (FLT3) mutation-positive and who are eligible to receive standard induction and consolidation chemotherapy; and
- Aggressive systemic mastocytosis (ASM) or mast cell leukaemia (MCL), with or without an associated hematologic non-mast cell lineage disorder (AHNMD).
The dose form of midostaurin (RYDAPT) for this indication is capsule.
The sponsor of midostaurin (RYDAPT) is Novartis Pharmaceuticals Australia Pty Limited.
(signed by)
Dr Anthony Gill
Delegate of the Secretary
22 June 2016