Retevmo (selpercatinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Eli Lilly and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s012lbl.pdf. Revised May 2024. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.	1
RETEVMO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with advanced or metastatic thyroid cancer with a RET gene fusion, as detected by an FDA-approved test, who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	RET oncogenic variants	Medullary Thyroid Cancer	Selpercatinib
FDA (1)	v::RET	Anaplastic Thyroid Cancer	Selpercatinib