Lilly scores full approval for Retevmo in thyroid cancer
12 Jun 2024
Drug ApprovalAccelerated ApprovalClinical Result
The FDA on Wednesday granted full approval to Eli Lilly’s selective RET kinase inhibitor Retevmo (selpercatinib) to treat adults and paediatric patients two years and older who have advanced or metastatic RET fusion-positive thyroid cancer, are radioactive iodine-refractory, and require systemic therapy.
The clearance follows a 2020 accelerated approval in the indication for patients 12 years and older, as well as one for paediatric patients awarded by the US regulator in May.
Last month’s accelerated approval also covered RET fusion-positive locally advanced or metastatic solid tumours and medullary thyroid cancer.
Supporting data
The accelerated approval was converted to full approval based on data from the Phase I/II LIBRETTO-001 study, which enrolled patients 12 years and older. Retevmo achieved an overall response rate (ORR) of 85% in 41 previously-treated thyroid cancer patients, and an ORR of 96% in 24 participants who were systemic-therapy naïve.
The former group of patients also had a median duration of response (DOR) of 26.7 months, while DOR has not yet been achieved in the latter cohort.
Supporting data for the paediatric approval was derived from 10 young adults and children with RET-altered solid tumours who participated in the Phase I/II LIBRETTO-121 study. Retevmo led to an ORR of 60%, and 83% of participants achieved a DOR of one year or longer.
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