del(5q) in myelodysplastic syndromes

2 EU-approved indications in myelodysplastic syndromes need a del(5q) result: lenalidomide (any line) and imetelstat (any line).

Line of therapy

Approved indications, Myelodysplastic syndromes
DrugBiomarker requirementRegimenSettingConditions
del(5q) deficiency1
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) negative1
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

See also

Label wording2

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. 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.
  2. 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).