BRIEF —Provisional TGA approval pathway - first determination decision for Lartruvo

US pharma major Eli Lilly’s Lartruvo (olaratumab) is the first medicine to be granted a provisional approval determination under the new provisional approval pathway which came into effect on March20, 2018, Australian regulator the Therapeutic Goods Administration (TGA) announced today.

Lartruvo, which gained regulatory approval in the USA and European Union in 2016 for certain types of soft tissue sarcoma (STS), was also granted an orphan drug designation for the treatment of soft tissue sarcoma on February9, 2018.

This provisional tag could see cancer drug in market two years earlier.

The provisional approval pathway allows sponsors to apply for time-limited provisional registration on the Australian Register of Therapeutic Goods (ARTG).

It provides access to certain promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.