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# Lilly Selpercatinib NDA Gets Priority Review
- URL: https://www.fdaweb.com/lilly-selpercatinib-nda-gets-priority-review/
- Published: 2020-01-30T12:00:00.000Z
- Updated: 2026-09-14T16:00:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145968

FDA has granted a priority review to an Eli Lilly NDA for selpercatinib and its use for treating patients with advanced RET fusion-positive non-small cell lung cancer, RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer. The agency has set a user fee review action target date for the third quarter.

The submission is based on data from the LIBRETTO-001 Phase 1/2 trial. The Phase 2 portion of the trial had a primary endpoint of objective response rate and secondary endpoints of duration of response, progression free survival and safety. “Treatment with selpercatinib at a twice-daily dose of 160 mg led to an objective response rate of 68%, with complete responses in 2% and partial responses in 66%,” the company says. The median duration of response was 20.3 months.