# 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

### Multiple myeloma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone | 1st line | Transplant-ineligible |
| None | Monotherapy | Maintenance | After autologous stem cell transplantation |
| None | + dexamethasone | 2nd line | After at least one prior therapy |

### Follicular lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | + rituximab | 2nd line | Grade 1–3A only; Previously treated |

### Mantle cell lymphoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | 2nd line | Relapsed or refractory |

### Myelodysplastic syndromes

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

## Products

### Revlimid

- Company: Bristol-Myers Squibb Pharma EEIG
- Target: Immunomodulatory agent (cereblon modulator)
- ATC: L04AX04
- EU approval: 14 Jun 2007
- Label revised: 9 Sep 2025
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/revlimid-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/revlimid
- Biosimilars and generics: Lenalidomide Mylan, Lenalidomide Krka (previously Lenalidomide Krka d.d. Novo mesto), Lenalidomide Accord, Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)

Mechanism (SmPC section 5.1): Binds cereblon in the CRL4 E3 ubiquitin ligase, recruiting Aiolos and Ikaros for ubiquitination and degradation, giving direct cytotoxic, immunomodulatory and anti-angiogenic effects.

## Label wording

- **Lenalidomide** (Revlimid), Multiple myeloma, maintenance: “Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf)
- **Lenalidomide** (Revlimid), Multiple myeloma, 1st line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf)
- **Lenalidomide** (Revlimid), Multiple myeloma, 2nd line: “Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf)
- **Lenalidomide** (Revlimid), Myelodysplastic syndromes, any line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf)
- **Lenalidomide** (Revlimid), Mantle cell lymphoma, 2nd line: “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).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf)
- **Lenalidomide** (Revlimid), Follicular lymphoma, 2nd line: “Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/revlimid-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/lenalidomide