Reason for request

Inclusion for REVLIMID 2.5 mg and REVLIMID 5 mg (B/7). Extension of indication for REVLIMID 5 mg (B/21) and REVLIMID 10 mg

Moderate improvement in the treatment of low-risk myelodysplastic syndromes with isolated 5q deletion when other therapeutic options are inadequate or inappropriate


  • REVLIMID now has Marketing Authorisation in the treatment of patients with transfusion-dependent anaemia due to a low-risk or intermediate-1-risk myelodysplastic syndrome (MDS) associated with an isolated 5q deletion.
  • In these patients, two studies have demonstrated the efficacy of lenalidomide in respect of transfusional independence, the increase in the haemoglobin level and the cytogenetic response, while its safety profile is comparable with that known for patients with myeloma.

Clinical Benefit



Clinical Added Value



Therapeutic use