Priority Review of Selpercatinib in RET-Driven Lung Cancer Granted by FDA
Posted: Tuesday, February 4, 2020
On January 29, Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the new drug application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion–positive non–small cell lung cancer (NSCLC). This oral agent is also being reviewed for RET-mutant medullary thyroid cancer and RET fusion–positive thyroid cancer.
The new drug application is based on data from the LIBRETTO-001 phase I/II trial in RET-altered lung and thyroid cancers. Two phase III trials of selpercatinib in treatment-naive patients with these RET-driven lung and thyroid cancers—LIBRETTO-431 AND LIBRETTO-531—are underway. Each trial is expected to enroll 400 patients.
In previous regulatory actions based on early data from the phase I/II LIBRETTO-001 trial, the FDA granted selpercatinib Breakthrough Therapy designation for treatment of patients with the following cancers:
- Metastatic RET fusion–positive NSCLC who require systemic therapy and have experienced disease progression after platinum-based chemotherapy and an anti–PD-1 or anti–PD-L1 therapy
- RET-mutant medullary thyroid cancer who require systemic therapy, have experienced disease progression after prior treatment, and have no acceptable alternative treatment option
- Advanced RET fusion–positive thyroid cancer who require systemic therapy, have experienced disease progression after prior treatment, and have no acceptable alternative treatment options.
