del(5q)
2 EU-approved indications of 2 drugs need a del(5q) result, in 1 tumour type, most of them in myelodysplastic syndromes.
Approved indications2
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Myelodysplastic syndromes2 | ||||
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 |
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) by tumour
Label wording2
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Lenalidomide (Revlimid)
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.
- Imetelstat (Rytelo)
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).