Australia to evaluate Lilly's Lartruvo under new provisional pathway

Australia's Therapeutic Goods Administration (TGA) said soft tissue sarcoma drug Lartruvo olaratumab from Eli Lilly and Co. (NYSE:LLY) was granted provisional approval determination, making the drug eligible for review under the country's new provisional approval pathway. Lartruvo is the first drug to be reviewed under the pathway, which was implemented on March 20 and allows for limited registration of products for new indications on the basis of preliminary clinical data.

The pathway comprises five steps: a provisional approval determination which lasts for up to six months, premarket registration, a provisional registration period, extension of provisional registration and transition to full registration. Provisional registration under the pathway is limited to six years, and sponsors may apply for full registration when sufficient clinical data to confirm the safety and efficacy of the product are available...