Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that RET oncogenic variants status confers therapeutic sensitivity to Selpercatinib in patients with Medullary Thyroid Cancer.

The U.S. Food and Drug Administration granted approval to selpercatinib 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.

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 advanced or metastatic medullary thyroid cancer (MTC) with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.

Citation

Eli Lilly and Company. Retevmo (selpercatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213246s011s013lbl.pdf. Revised September 2024. Accessed October 30, 2024. 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.

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-09-27	Food and Drug Administration	Indication received traditional approval.
2024-05-29	Food and Drug Administration	Indication received accelerated approval.