Lenalidomide

Lenalidomide (Revlimid, Bristol-Myers Squibb Pharma EEIG) has 6 EU-approved indications in 4 tumour types. 1 needs a biomarker result: del(5q) (1).
Approved indications of Lenalidomide
Biomarker requirementRegimenSettingConditions
Multiple myeloma3
None
+ dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone
1L
Transplant-ineligible
None
Monotherapy
Maint.
After autologous stem cell transplantation
None
+ dexamethasone
2L
After at least one prior therapy
Follicular lymphoma1
None
+ rituximab
2L
Grade 1–3A only; Previously treated
Mantle cell lymphoma1
None
Monotherapy
2L
Relapsed or refractory
Myelodysplastic syndromes1
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
Full text of section 4.1 (therapeutic indications)

Multiple myeloma Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Myelodysplastic syndromes 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. Mantle cell lymphoma Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4.4 and 5.1). Follicular lymphoma Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).

Label history

68 changes to the Revlimid label since 2007, 7 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes