Shots:

• The NDA is based on P-I/II LIBRETTO-001 study assessing selpercatinib in patients with advanced RET fusion+ NSCLC & thyroid cancer and RET-mutant MTC. The study included P-I as dose-escalation phase and P-II dose-expansion phase
• Selpercatinib has received FDA’s BT and ODD for the above mention indications and is currently being evaluated in two P-III studies LIBRETTO-431 for patients with treatment-naïve RET fusion+ NSCLC- and LIBRETTO-531 for patients with treatment-naïve RET-mutant MTC
• Selpercatinib is a highly selective and potent investigational therapy for multiple cancer indications harboring abnormalities in the RET kinase with its anticipated PDUFA date in Q3’2020

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