RETEVMO, a kinase inhibitor targeting RET gene alterations, is indicated for treating specific types of advanced or metastatic cancers, with its approval for certain solid tumors based on observed response rates and duration, pending confirmatory trials.
Mechanism of Action and Therapeutic Indications
RETEVMO (selpercatinib) is a kinase inhibitor designed to treat cancers driven by specific alterations in the rearranged during transfection (RET) gene. Its therapeutic effect stems from inhibiting RET signaling pathways. It is indicated for adult patients with RET fusion-positive non-small cell lung cancer (NSCLC); adult and pediatric patients (2 years and older) with RET-mutant medullary thyroid cancer (MTC) requiring systemic therapy; and adult and pediatric patients (2 years and older) with RET fusion-positive thyroid cancer requiring systemic, radioactive iodine-refractory therapy. Additionally, it's indicated for adult and pediatric patients (2 years and older) with other RET fusion-positive solid tumors that have progressed or have no satisfactory alternatives; this latter indication received accelerated approval based on overall response rate and duration of response. Detailed efficacy data from specific clinical studies (14.1-14.4) are referenced in the full prescribing information but are not fully detailed in the provided highlights.