Posted by Michael Wonder on 16 Apr 2018
Provisional approval pathway - first determination decision
16 April 2018 - Olaratumab (Lartruvo) is the first medicine to be granted a provisional approval determination under the new provisional approval pathway which came into effect on 20 March 2018.
Lartruvo was also granted an orphan drug designation for the treatment of soft tissue sarcoma on 9 February 2018.
Details of prescription medicines that have an approved provisional determination, priority review determination or orphan drug designation are published on the TGA website: Prescription medicines determination and designation notices.
