Selpercatinib

Selpercatinib (Retsevmo, Eli Lilly Nederland B.V.) has 4 EU-approved indications in 3 tumour types. Each needs a biomarker result: RET (4).
Approved indications of Selpercatinib
Biomarker requirementRegimenSettingConditions
Non-small cell lung cancer1
RET fusion
Monotherapy
Any line
advanced
Not previously treated with a RET inhibitor
Thyroid cancer2
RET fusion
Monotherapy
Any line
advanced
Radioactive iodine-refractory (if radioactive iodine is appropriate); aged 2 years and older
RET mutation
Monotherapy
Any line
advanced
Medullary thyroid cancer only; Aged 2 years and older
Solid tumours, tumour-agnostic1
RET fusion
Monotherapy
Any line
advanced
Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older
Full text of section 4.1 (therapeutic indications)

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. For biomarker-based patient selection, see section 4.2. Retsevmo as monotherapy is indicated for the treatment of adults and paediatric patients 2 years of age and older with: – advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate). For biomarker-based patient selection, see section 4.2. – advanced RET-mutant medullary thyroid cancer (MTC). For biomarker-based patient selection, see section 4.2. – advanced RET fusion-positive solid tumours, when treatment options not targeting RET provide limited clinical benefit, or have been exhausted (see sections 4.4 and 5.1). For biomarker-based patient selection, see section 4.2.

Label history

25 changes to the Retsevmo label since 2021, 5 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes