COMMONWEALTH OF AUSTRALIA
Department of Health
Therapeutic Goods Administration
THERAPEUTIC GOODS ACT 1989
DESIGNATION OF Crizotinib (XALKORI) 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 Crizotinib (XALKORI) as an orphan drug on 23 September 2016 for the treatment of ROS1-positive non-small cell lung cancer (NSCLC).
The dose form of Crizotinib (XALKORI) for this indication is capsule.
The sponsor of Crizotinib (XALKORI) is Pfizer Australia Pty Ltd.
(Signed by)
Dr Anthony Gill
Delegate of the Secretary
23 September 2016