Retsevmo (selpercatinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

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

Indication	Statements
Retsevmo as monotherapy is indicated for the treatment of adults with advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.	1
Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate).	1
Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC).	1
Retsevmo as monotherapy is indicated for the treatment of adults with advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	v::RET	Non-Small Cell Lung Cancer	Selpercatinib
Sensitivity (+)	v::RET	Papillary Thyroid Cancer	Selpercatinib
Sensitivity (+)	RET p.M918T	Medullary Thyroid Cancer	Selpercatinib
Sensitivity (+)	v::RET	Any solid tumor	Selpercatinib