Selpercatinib is used for selected cancers in which a clinically relevant RET gene alteration has been identified. Approved uses differ by jurisdiction and can change as regulatory authorities evaluate new evidence.
RET fusion-positive NSCLC
Current U.S. labeling indicates selpercatinib for adults with locally advanced or metastatic non-small cell lung cancer containing a RET gene fusion detected by an FDA-approved test.
RET fusions are uncommon in NSCLC, which makes molecular testing important when evaluating potentially targetable disease.
RET-mutant medullary thyroid cancer
Selpercatinib is indicated in the United States for adults and children aged 2 years and older with advanced or metastatic medullary thyroid cancer containing a RET mutation who require systemic therapy.
The FDA granted traditional approval for this indication in September 2024 after earlier accelerated approval.
RET fusion-positive thyroid cancer
Current U.S. labeling includes adults and pediatric patients aged 2 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and whose disease is radioactive-iodine-refractory when radioactive iodine is appropriate.
Other RET fusion-positive solid tumors
As of July 2026, the FDA has granted traditional approval for selpercatinib in adults and pediatric patients aged 2 years and older with locally advanced or metastatic RET fusion-positive solid tumors that have progressed on or after prior systemic treatment or have no satisfactory alternative treatment options.
European indications
The EMA describes Retsevmo for advanced RET fusion-positive NSCLC, advanced RET fusion-positive thyroid cancer, advanced RET-mutant medullary thyroid cancer and selected advanced RET fusion-positive solid tumors. The European wording and patient-selection requirements should be checked against the current EU product information.
Approved versus investigational use
A clinical study involving selpercatinib does not automatically mean that an indication is approved. Early-stage adjuvant research, for example, has produced important clinical results, but a research finding should not be presented as an approved indication unless the applicable regulator has authorized it.