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Selpercatinib Gets Full Approval for Thyroid Cancers

June 12, 2024

The FDA granted full approval to selpercatinib (Retevmo; Lilly) for adults and children older than 2 with advanced or metastatic RET fusion–positive thyroid cancer who need systemic therapy and are refractory to radioactive iodine, assuming that would be an appropriate treatment option; the RET inhibitor received accelerated approval for this indication in patients 12 and older in May 2020. The decision was based on findings from the LIBRETTO-001 trial, which included 65 patients divided into two cohorts depending on whether they’d already had any therapy. The overall response rate was 85% in 41 patients who had already received treatment, and 96% in patients who were newly diagnosed. The median duration of response was 26.7 months and not evaluable, respectively.

 

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