Posted by Michael Wonder on 07 Feb 2018
Priority review pathway - first registration decision
6 February 2018 - Alectinib hydrochloride (Alecensa) is the first medicine to be registered on the Australian Register of Therapeutic Goods via TGA's new priority review pathway, which came into effect on 1 July 2017.
The application extends the previously registered indications to include the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small-cell lung cancer. The extension of indication was registered on the ARTG on 30 January 2018.
This medicine was also the first to be granted a priority review determination (previously known as priority review designation) by the TGA.
