What is the role of selpercatinib (Retevmo) in the treatment of non-small cell lung cancer (NSCLC)?

Updated: Jul 15, 2021
  • Author: Winston W Tan, MD, FACP; Chief Editor: Nagla Abdel Karim, MD, PhD  more...
  • Print
Answer

Selpercatinib is the first targeted therapy to be approved by the FDA for tumors that have rearranged during transfection (RET) mutations. It is indicated for metastatic RET-fusion–positive NSCLC. 

Accelerated approval in May 2020 for use in NSCLC was based on the open-label LIBRETTO-001 phase I/II clinical trial (n = 144). ORR was 64% in treatment-experienced patients (n = 105) and 85% in treatment-naïve patients (n = 39). The phase III confirmatory trial (LIBRETTO-431) is under way. [203]

Another RET inhibitor, pralsetinib (Gavreto) was granted accelerated approval in September 2020 for use in metastatic RET-fusion-positive NSCLC. Its efficacy for RET fusion-positive NSCLC was based on a multicenter, open-label, multi-cohort clinical trial, ARROW (n=87). The ORR was 57%; 80% of responding patients had responses lasting 6 months or longer. The ORR for patients who were never systemically treated was 70%; 58% of responding patients had responses lasting 6 months or longer. [204]


Did this answer your question?
Additional feedback? (Optional)
Thank you for your feedback!