Lenalidomide

(Revlimid®)

Lenalidomide

Drug updated on 9/4/2024

Dosage FormCapsule (oral; 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg)
Drug ClassThalidomide analogues
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of multiple myeloma (MM), in combination with dexamethasone.
  • Indicated for the treatment of MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
  • Indicated for the treatment of 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.
  • Indicated for the treatment of mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
  • Indicated for the treatment of previously treated follicular lymphoma (FL), in combination with a rituximab product.
  • Indicated for the treatment of previously treated marginal zone lymphoma (MZL), in combination with a rituximab product.

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Summary
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  • Revlimid (lenalidomide) is indicated for the treatment of multiple myeloma (MM) in combination with dexamethasone, for the treatment of MM as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT), for the treatment of 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, for the treatment of mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib, for the treatment of previously treated follicular lymphoma (FL) in combination with a rituximab product, and for the treatment of previously treated marginal zone lymphoma (MZL) in combination with a rituximab product.
  • This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
  • Multiple Myeloma (RRMM): IRd (Ixazomib, Lenalidomide, Dexamethasone): Progression-free survival (PFS) significantly longer than Rd, V, Dex, and Pom-dex, but significantly shorter than DRd; overall survival (OS) significantly longer than V, Dex, and Pom-dex; overall response rate (ORR) significantly higher than Rd, V, and Dex but lower than KRd and DRd.
  • Chronic Lymphocytic Leukemia (CLL): Lenalidomide Maintenance Therapy: Statistically significant prolongation in progression-free survival (PFS) with a hazard ratio (HR) of 0.43; no significant difference in overall survival (OS) (HR, 0.62).
  • Diffuse Large B-Cell Lymphoma (DLBCL): Lenalidomide Monotherapy: Pooled objective response rate (ORR) of 0.33, with better response in non-GCB phenotype (0.50) compared to GCB phenotype (0.06); median progression-free survival (PFS) ranged from 2.6 to 34 months; median overall survival (OS) ranged from 7.8 to 37 months.
  • Lenalidomide in Chronic Lymphocytic Leukemia (CLL): Higher incidence of serious adverse events (OR 4.64) and no significant difference in Grade 3-4 neutropenia (OR 2.30), treatment discontinuation (OR 0.76), and fatal adverse events (OR 0.86) compared to observation/placebo.
  • Lenalidomide in Diffuse Large B-Cell Lymphoma (DLBCL): Notable serious treatment-related adverse events include neutropenia, thrombocytopenia, respiratory disorders, anemia, and diarrhea.
  • Multiple Myeloma (SPM Risk): Increased risk of second primary malignancies in multiple myeloma patients (RR 1.42), with no increased risk observed in other hematologic malignancies.
  • Thromboprophylaxis in Multiple Myeloma: Despite thromboprophylaxis, a pooled incidence of venous thromboembolism (6.2%) was observed, with higher risk noted when lenalidomide was combined with low-dose dexamethasone plus proteasome inhibitors.

Product Monograph / Prescribing Information

Document TitleYearSource
Revlimid (lenalidomide) Prescribing Information.2023Bristol-Myers Squibb Company, Princeton, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines