# 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

### Non-small cell lung cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| RET fusion | Monotherapy | Advanced | Not previously treated with a RET inhibitor |

### Thyroid cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| RET fusion | Monotherapy | Advanced | Radioactive iodine-refractory (if radioactive iodine is appropriate); aged 2 years and older |
| RET mutation | Monotherapy | Advanced | Medullary thyroid cancer only; Aged 2 years and older |

### Solid tumours, tumour-agnostic

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Products

### Retsevmo

- Company: Eli Lilly Nederland B.V.
- Target: RET kinase inhibitor
- Class: Other protein kinase inhibitors
- ATC: L01EX22
- EU approval: 11 Feb 2021
- Label revised: 3 Jul 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/retsevmo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/retsevmo

Mechanism (SmPC section 5.1): Selpercatinib inhibits wild-type and mutant RET receptor tyrosine kinase isoforms and fusions, suppressing downstream oncogenic signalling and tumour cell proliferation.

## Label wording

- **Selpercatinib** (Retsevmo), Non-small cell lung cancer, advanced: “advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf)
- **Selpercatinib** (Retsevmo), Thyroid cancer, advanced: “advanced RET fusion-positive thyroid cancer who are radioactive iodine-refractory (if radioactive iodine is appropriate).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf)
- **Selpercatinib** (Retsevmo), Thyroid cancer, advanced: “advanced RET-mutant medullary thyroid cancer (MTC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf)
- **Selpercatinib** (Retsevmo), Solid tumours, tumour-agnostic, advanced: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/retsevmo-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/selpercatinib