REVLIMID
Revlimid (lenalidomide) is a thalidomide analogue indicated for the treatment of several hematologic malignancies, including multiple myeloma, mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma. It is utilized both as a combination therapy with agents like dexamethasone or rituximab and as a maintenance treatment for multiple myeloma following autologous hematopoietic stem cell transplantation. The medication is also indicated for patients with transfusion-dependent anemia resulting from specific low- or intermediate-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality.
How REVLIMID Works
Lenalidomide targets cereblon, a component of the E3 ubiquitin ligase enzyme complex, to initiate the degradation of specific substrate proteins such as Aiolos and Ikaros. This mechanism results in direct antineoplastic activity by inhibiting cell proliferation and inducing apoptosis in various hematopoietic tumor cells. Additionally, the drug exerts immunomodulatory effects by activating T cells and natural killer cells, enhancing antibody-dependent cell-mediated cytotoxicity, and inhibiting the production of pro-inflammatory cytokines.
Details
- Status
- Prescription
- First Approved
- 2005-12-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE
REVLIMID Approval History
What REVLIMID Treats
5 indicationsREVLIMID is approved for 5 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
- Myelodysplastic Syndromes
- Mantle Cell Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
REVLIMID Boxed Warning
EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy test...
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID ® treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment [see Warnings and Precautions ( 5.1 ), and Medication Guide ( 17 )]. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the Lenalidomide REMS program ( 5.2 ). Information about the Lenalidomide REMS program is available at www.lenalidomiderems.com or by calling the REMS Call Center at 1-888-423-5436. Hematologic Toxicity (Neutropenia and Thrombocytopenia) REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors [see Dosage and Administration ( 2.2 )] . Venous and Arterial Thromboembolism REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as r
REVLIMID Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REVLIMID FDA Label Details
ProIndications & Usage
FDA Label (PDF)REVLIMID is a thalidomide analogue indicated for the treatment of adult patients with: • Multiple myeloma (MM), in combination with dexamethasone . • MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) . • 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 . • Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib . • Previously treated follicul...
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that cause...
REVLIMID Patents & Exclusivity
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.