Lilly gets full approval for Retevmo in thyroid cancer
The FDA has granted full approval to Eli Lilly’s selective RET kinase inhibitor, Retevmo (selpercatinib), for the treatment of adults and pediatric patients aged two years and older with advanced or metastatic RET fusion-positive thyroid cancer. These patients must be refractory to radioactive iodine and require systemic therapy for their condition. This decision upgrades the drug's 2020 accelerated approval for patients aged 12 years and older, as well as the approval given in May for pediatric patients.
Last month's accelerated approval also extended to RET fusion-positive locally advanced or metastatic solid tumors and medullary thyroid cancer. The transition from accelerated to full approval was supported by data from the Phase I/II LIBRETTO-001 study, which included patients aged 12 years and older. In this study, Retevmo showed an overall response rate (ORR) of 85% in 41 previously-treated thyroid cancer patients. Among 24 participants who had not previously undergone systemic therapy, the ORR was 96%. For the previously-treated group, the median duration of response (DOR) was 26.7 months. In contrast, the DOR for the systemic-therapy naïve group has not yet been reached.
The pediatric approval was based on results from the Phase I/II LIBRETTO-121 study, which involved 10 young adults and children with RET-altered solid tumors. The drug achieved an ORR of 60% in this cohort, with 83% of these patients experiencing a DOR of one year or longer.
Retevmo's approval represents a significant development in the treatment of RET fusion-positive cancers, offering a new hope for patients who have limited options.
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