# Myelodysplastic syndromes

The EU has approved 2 indications of 2 drugs in myelodysplastic syndromes. 1 of them needs a biomarker result: del(5q) (1).

## Approved indications

### del(5q) deficiency

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Lenalidomide](https://oncolabels.com/drugs/lenalidomide) (Revlimid) | Isolated deletion 5q cytogenetic abnormality | Monotherapy | Any line | Transfusion-dependent anaemia; low- or intermediate-1-risk myelodysplastic syndromes; when other therapeutic options are insufficient or inadequate |

### del(5q) negative

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Imetelstat](https://oncolabels.com/drugs/imetelstat) (Rytelo) | 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 |

## Label wording

- **Lenalidomide** (Revlimid), Myelodysplastic syndromes, any line: “Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf)
- **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/tumours/myelodysplastic-syndromes