FDA approved Revlimid (lenalidomide) for Multiple Myeloma and Other IndicationsFDA approved Revlimid for several blood cancers and related conditions.

FDA From the archive Source published December 27, 2005 Summary added May 2, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

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Key Takeaway

Consider Revlimid for MM, MDS with del 5q, MCL, FL, and MZL; adjust dose for renal function and monitor hematologic toxicity.

The FDA has approved Revlimid (lenalidomide), a thalidomide analogue, for multiple indications in hematologic malignancies. For multiple myeloma, it is indicated in combination with dexamethasone for treatment and as maintenance therapy following autologous hematopoietic stem cell transplantation. It is also approved for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality, mantle cell lymphoma that has relapsed or progressed after two prior therapies including bortezomib, and previously treated follicular lymphoma and marginal zone lymphoma in combination with a rituximab product. Notably, Revlimid is not indicated for chronic lymphocytic leukemia outside of controlled clinical trials. This approval provides clinicians with a versatile oral agent for several hematologic conditions, but careful monitoring for hematologic toxicities and dose adjustments based on renal function are required.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Revlimid (lenalidomide) is a thalidomide analogue with immunomodulatory, anti-angiogenic, and antineoplastic properties. The exact mechanism is not fully described in the label.

Indication & Patient Population

Revlimid is indicated for adult patients with: multiple myeloma (in combination with dexamethasone and as maintenance after auto-HSCT); transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) with deletion 5q abnormality; mantle cell lymphoma (MCL) relapsed or progressed after two prior therapies including bortezomib; previously treated follicular lymphoma (FL) in combination with a rituximab product; and previously treated marginal zone lymphoma (MZL) in combination with a rituximab product. It is not indicated for CLL outside controlled trials.

Dosing & Administration

For MM combination therapy: 25 mg once daily on Days 1-21 of 28-day cycles with dexamethasone. For MM maintenance after auto-HSCT: 10 mg once daily continuously (Days 1-28 of 28-day cycles), may increase to 15 mg after 3 cycles if tolerated. For MDS: 10 mg once daily. For MCL: 25 mg once daily on Days 1-21 of 28-day cycles. For FL or MZL: 20 mg once daily on Days 1-21 of 28-day cycles for up to 12 cycles. Dose adjustments for renal impairment based on creatinine clearance. Dose modifications for hematologic toxicities are provided in the label.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Revlimid is a thalidomide analogue and is not indicated for CLL outside controlled trials. Hematologic toxicities (neutropenia, thrombocytopenia) require dose adjustments. Renal impairment requires dose adjustment. Other warnings may apply; see full prescribing information.

Place in Therapy

Revlimid is an oral immunomodulatory agent used in multiple myeloma (combination and maintenance), MDS with del 5q, and certain lymphomas (MCL, FL, MZL). It is not recommended for CLL outside clinical trials.

The FDA has approved Revlimid (lenalidomide) for several blood cancers and related conditions. This oral medication is a thalidomide analogue. It is used in combination with other drugs for multiple myeloma, both as treatment and as maintenance therapy after a stem cell transplant. It is also approved for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes with a specific chromosome abnormality (deletion 5q). Additionally, Revlimid is approved for mantle cell lymphoma that has relapsed or progressed after two prior therapies, and for previously treated follicular lymphoma and marginal zone lymphoma when given with a rituximab product.

This approval means that patients with these conditions have a new treatment option that can be taken by mouth. However, Revlimid is not approved for chronic lymphocytic leukemia outside of controlled clinical trials. The drug requires careful monitoring for blood cell count changes and dose adjustments based on kidney function.

If you or a loved one has one of these conditions, talk to your doctor about whether Revlimid might be an appropriate treatment option. Your doctor can help you understand the benefits and risks based on your specific health situation.

What this means for you:

Revlimid is a new oral drug for several blood cancers; talk to your doctor if it may be right for you.

Study Details

Study typeFda approval

PublishedDec 2005

View Original Abstract ↓

1 INDICATIONS AND USAGE REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: • Multiple myeloma (MM), in combination with dexamethasone ( 1.1 ). • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) ( 1.1 ). • Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities ( 1.2 ). • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib ( 1.3 ). • Previously treated follicular lymphoma (FL), in combination with a rituximab product ( 1.4 ). • Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product ( 1.5 ). Limitations of Use: • REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials ( 1.4 ). 1.1 Multiple Myeloma REVLIMID in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM). REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT). 1.2 Myelodysplastic Syndromes REVLIMID is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. 1.3 Mantle Cell Lymphoma REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. 1.4 Follicular Lymphoma REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL). 1.5 Marginal Zone Lymphoma REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL). 1.6 Limitations of Use REVLIMID is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5) ] .

FDA approved Revlimid (lenalidomide) for Multiple Myeloma and Other IndicationsFDA approved Revlimid for several blood cancers and related conditions.

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FDA approved Revlimid (lenalidomide) for Multiple Myeloma and Other IndicationsFDA approved Revlimid for several blood cancers and related conditions.

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