Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has conditionally authorized selpercatinib for the treatment of adult and adolescent (12 years and older) patients with advanced RET-mutant medullary thyroid cancer. This indication is based on LIBRETTO-001 (a phase 1/2, multicenter, open-label, single-arm clinical study), where the most common variant was p.M918T, followed by extracelluar cysteine mutations.

This is written in the approval document as:

Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC).

Citation

Eli Lilly Nederland B.V. Retsevmo (selpercatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf. Revised March 2024. Accessed March 22, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	RET p.M918T	Medullary Thyroid Cancer	Selpercatinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2022-09-02	European Medicines Agency	Indication received approval from the European Commission.