FDA Grants Priority Review to New Drug Application for the RET Kinase Inhibitor Selpercatinib

Web Exclusives - FDA Updates, In the News, Lung Cancer, Thyroid Cancer

On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. The FDA is aiming to provide its decision on the approval of selpercatinib in the third quarter of 2020.

Previously, the FDA granted breakthrough therapy and orphan drug designations for selpercatinib to treat certain patients with advanced RET fusion-positive thyroid cancer and those with RET-altered NSCLC or MTC. The agent was also granted orphan drug designation by the FDA for the treatment of patients with RET fusion-positive NSCLC, RET-mutant MTC, and RET fusion-positive thyroid cancer.

“We are pleased the FDA granted priority review status for the NDA for selpercatinib. This represents an important step toward providing a new precision therapy for people living with certain RET-driven cancers,” stated Anne E. White, President, Lilly Oncology, in a company press release.

Key Takeaways:

  • The NDA includes data from the phase 1/2 LIBRETTO-001 clinical trial, the largest study of patients with RET-driven lung and thyroid cancers treated with an RET inhibitor. Data from phase 2 of the study showed an overall response rate (ORR) of 77% in evaluable patients with RET fusion-positive cancers. In 2019, updated data showed an ORR of 68% in patients with lung cancer and an ORR of 56% in patients with thyroid cancer.
  • RET fusions have been identified in approximately 2% of NSCLC, 10% to 20% of papillary and other thyroid cancers, and a subset of other cancers. Activating RET point mutations account for approximately 60% of MTC. RET fusion cancers and RET-mutant MTC depend on this single activated kinase for their uncontrolled growth.
  • In December 2019, Lilly Oncology opened 2 phase 3 trials: LIBRETTO-431, which will evaluate selpercatinib in treatment-naïve patients with RET fusion-positive NSCLC, and LIBRETTO-531, which will evaluate selpercatinib in treatment-naïve patients with RET-mutant MTC. Each trial will enroll 400 patients.
Related Items
FDA NEWS: February 5, 2021 to February 22, 2021
TOP - March 2021 Vol 14, No 2 published on March 11, 2021 in FDA Updates
“Astonishing Results” Seen with First-Line Lorlatinib for the Treatment of ALK-Positive NSCLC
Patricia Stewart
TOP - January 2021 Vol 14, No 1 published on February 9, 2021 in Lung Cancer
Cemiplimab Potential New Treatment Option for Patients with Advanced NSCLC and PD-L1 ≥50%
Patricia Stewart
TOP - January 2021 Vol 14, No 1 published on February 9, 2021 in Lung Cancer
FDA News: November 25th To December 18th
TOP - January 2021 Vol 14, No 1 published on February 9, 2021 in FDA Updates
NSCLC Year in Review Introduction
2020 Year in Review - Non–Small-Cell Lung Cancer published on January 29, 2021 in Lung Cancer
ADAURA Trial: Osimertinib in Resected EGFR-Mutated NSCLC
2020 Year in Review - Non–Small-Cell Lung Cancer published on January 29, 2021 in Lung Cancer
Lower Dose of Afatinib Shows Promising Clinical Efficacy in Patients with NSCLC and EGFR Mutation
2020 Year in Review - Non–Small-Cell Lung Cancer published on January 29, 2021 in Lung Cancer
Bevacizumab + Osimertinib Did Not Increase Progression-Free Survival versus Osimertinib Alone in Patients with Advanced Adenocarcinoma and EGFR T790M Mutations
2020 Year in Review - Non–Small-Cell Lung Cancer published on January 29, 2021 in Lung Cancer
Patritumab Deruxtecan Shows Promise in Treating Patients with EGFR-Mutated NSCLC
2020 Year in Review - Non–Small-Cell Lung Cancer published on January 29, 2021 in Lung Cancer
Inhibition of VEGFR and EGFR with Apatinib + Gefitinib as First-Line Therapy Increased Progression-Free Survival
2020 Year in Review - Non–Small-Cell Lung Cancer published on January 29, 2021 in Lung Cancer
Last modified: April 27, 2020