Lenalidomide
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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