Regulatory approval

Published by the Food and Drug Administration. Approved

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).

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	v::RET	Anaplastic Thyroid Cancer	Selpercatinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2024-06-12	Food and Drug Administration	Indication received traditional approval.
2024-05-29	Food and Drug Administration	Indication received accelerated approval.