Posted by Michael Wonder on 21 Sep 2022
FDA approves selpercatinib for locally advanced or metastatic RET fusion positive solid tumours
21 September 2022 - Today, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly) for adult patients with locally advanced or metastatic solid tumours with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.
Efficacy was demonstrated in LIBRETTO-001, a multi-centre, open-label, multi-cohort trial that evaluated 41 patients with RET fusion-positive tumours (other than non-small cell lung cancer and thyroid cancer) with disease progression on or following prior systemic treatment or who had no satisfactory alternative treatment options.
