# Imetelstat

Imetelstat (Rytelo, Geron Netherlands B.V.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Myelodysplastic syndromes

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Without an isolated deletion 5q cytogenetic (non-del 5q) abnormality | Monotherapy | Any line | Transfusion-dependent anaemia; very low, low or intermediate risk MDS; unsatisfactory response to or ineligible for erythropoietin-based therapy |

## Products

### Rytelo

- Company: Geron Netherlands B.V.
- Target: Oligonucleotide telomerase inhibitor
- Class: Other antineoplastic agents
- ATC: L01XX80
- EU approval: 7 Mar 2025
- Label revised: 15 May 2025
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/rytelo-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/rytelo-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/rytelo

Mechanism (SmPC section 5.1): Oligonucleotide that binds the template region of telomerase's RNA component (hTR), blocking telomere binding; shortens telomeres and causes apoptosis of malignant stem and progenitor cells.

## Label wording

- **Imetelstat** (Rytelo), Myelodysplastic syndromes, any line: “Rytelo is indicated as monotherapy for the treatment of adult patients with transfusion-dependent anaemia due to very low, low or intermediate risk myelodysplastic syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/rytelo-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/imetelstat