Imetelstat
Imetelstat (Rytelo, Geron Netherlands B.V.) has 1 EU-approved indication in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Myelodysplastic syndromes1 | |||
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 |
Full text of section 4.1 (therapeutic indications)
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).
Label history
There is no record of changes to the Rytelo label that oncolabels can read yet. EMA publishes it some months after the first approval.