Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that v::RET status confers therapeutic sensitivity to Selpercatinib in patients with Any solid tumor.
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).
This statement is based on a regulatory approval from the Food and Drug Administration:
RETEVMO is a kinase inhibitor indicated 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. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).