The FDA recently granted priority review to selpercatinib for the treatment of patients with advanced RET fusion-positive NSCLC, and other RET cancers, according to a news release. 

Selpercatinib, also known as investigational agent LOXO-292, is an oral RET-signal inhibitor that targets RET fusions and mutations and also inhibits resistance mechanisms.

Data from the LIBRETTO-001 Phase 1/2 trial were used to support the New Drug Application for selpercatinib. The trial studied 105 patients with RET fusion-positive NSCLC and found a 68% overall response rate. Further, ORR was 85% among the 34 treatment naïve NSCLC patients.

"In this large cohort, selpercatinib's response rate, durability, robust CNS activity, and safety show promise," Alexander Drilon, MD, lead investigator, Memorial Sloan Kettering Cancer Center told MD /alert. "Furthermore, this continues to confirm that RET fusions are clinically targetable alterations, placing them in the company of activating EGFR/ALK/ROS1 alterations."

Selpercatinib previously received orphan drug designation from the FDA in 2019. The FDA is expected to make a decision on the approval of selpercatinib in Q3 of 2020.

By MD/Alert Staff