COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Alectinib 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 Alectinib as an orphan drug on 27th October 2015 for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.
The dose form of Alectinib for this indication is capsule.
The sponsor of Alectinib is Roche Products Pty Limited.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
17 November 2015