Revlimid (lenalidomide)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved June 2013

Specific Treatments:

mantle cell lymphoma

Therapeutic Areas

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General Information

Revlimid (lenalidomide), a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties.

Revlimid is specifically indicated forr the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

The recommended dose in this population is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity.

Clinical Results

FDA Approval
The FDA approval of Revlimid for mantle cell lymphoma was based on a multicenter, single-arm, open-label trial of single-agent lenalidomide in 134 subjects with mantle cell lymphoma who had relapsed after or were refractory to bortezomib or a bortezomib-containing regimen. Subjects with a creatinine clearance >60 mL/min were given lenalidomide at a dose of 25 mg once daily for 21 days every 28 days. Subjects with a creatinine clearance >30 mL/min and <60 mL/min were given lenalidomide at a dose of 10 mg once daily for 21 days every 28 days. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent. The endpoints were overall response rate (ORR) and duration of response (DOR). The ORR was 26% and the median DOR was 16.6 months.

Side Effects

Adverse events associated with the use of Revlimid for mantle cell lymphoma may include, but are not limited to, the following:

  • neutropenia
  • thrombocytopenia
  • fatigue
  • diarrhea
  • anemia
  • nausea
  • cough
  • pyrexia
  • rash
  • dyspnea
  • pruritus
  • constipation
  • peripheral edema
  • leukopenia

Mechanism of Action

Revlimid (lenalidomide) is an analogue of thalidomide with immunomodulatory, antiangiogenic, and antineoplastic properties. Lenalidomide inhibits proliferation and induces apoptosis of certain hematopoietic tumor cells including multiple myeloma, mantle cell lymphoma, and del (5q) myelodysplastic syndromes in vitro. Lenalidomide causes a delay in tumor growth in some in vivo nonclinical hematopoietic tumor models including multiple myeloma. Immunomodulatory properties of lenalidomide include activation of T cells and natural killer (NK) cells, increased numbers of NKT cells, and inhibition of pro-inflammatory cytokines (e.g., TNF-a and IL-6) by monocytes.

Additional Information

For additional information regarding Revlimid or mantle cell lymphoma, please visit the Revlimid web page.