Selpercatinib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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