COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF brigatinib (ALUNBRIG) 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 brigatinib (ALUNBRIG) as an orphan drug on 28 July 2017 for the treatment of patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer.
The dose form of brigatinib (ALUNBRIG) for this indication is film-coated tablet.
The sponsor of brigatinib (ALUNBRIG) is Takeda Pharmaceuticals Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
28 July 2017