Therapeutic Response

v::RET status confers therapeutic sensitivity to Selpercatinib in patients with Any solid tumor.

Statements

Source and description
Retevmo (selpercatinib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to selpercatinib for the treatment of adult and pediatric patients 2 years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. The product label states that this indication is approved under accelerated approval based on overall response rate and duration of response and that continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
Retsevmo (selpercatinib) [product information]. EMA. The European Medicines Agency (EMA) has conditionally authorized selpercatinib for the treatment of adult patients with advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted.