Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that RET p.M918T status confers therapeutic sensitivity to Selpercatinib in patients with Medullary Thyroid Cancer.
The European Medicines Agency (EMA) has conditionally authorized selpercatinib for the treatment of adult and adolescent (12 years and older) patients with advanced RET-mutant medullary thyroid cancer. This indication is based on LIBRETTO-001 (a phase 1/2, multicenter, open-label, single-arm clinical study), where the most common variant was p.M918T, followed by extracelluar cysteine mutations.
This statement is based on a regulatory approval from the European Medicines Agency:
Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC).