Lenalidomide and Pomalidomide: Immunomodulating Drug Therapies in Multiple Myeloma

The American Cancer Society estimates that oncologists will diagnose about 34,920 new cases of multiple myeloma in 2021 with about 12,410 deaths expected to occur.

Multiple myeloma (MM) is a cancer that forms in plasma cells. Healthy plasma cells are an important part of the immune system and help fight infections. In MM, cancerous plasma cells producing abnormal proteins overwhelm healthy blood cells and cause complications including fatigue, anemia, and the inability to fight infections.1 

MM is rare, with fewer than 200,000 cases occurring annually in the United States.1 The American Cancer Society estimates that oncologists will diagnose about 34,920 new cases of MM in 2021 with about 12,410 deaths expected to occur.2

Therapy for MM may include a combination of targeted therapy, immunotherapy, corticosteroids, chemotherapy, radiation therapy, and bone marrow transplants.1

Lenalidomide and Pomalidomide

The thalidomide analogues lenalidomide (Revlimid; Bristol Myers Squibb) and pomalidomide (Pomalyst; Celegene) are immunomodulating drugs for the treatment of MM.3,4 Thalidomide, a known human teratogen, causes serious birth defects or embryo-fetal death. Since lenalidomide and pomalidomide are related to thalidomide, they have similar teratogenic adverse effects.

FDA Approval History

The FDA initially approved lenalidomide in 2005 for treatment of transfusion dependent myelodysplastic syndrome. In 2015, the FDA approved pomalidomide when its indication was expanded to include treatment of MM in combination with dexamethasone. Further, the FDA approved the first generic product lenalidomide in 2021.5

Pomalidomide was initially approved by the FDA as an orphan drug in 2013 for patients with multiple myeloma. Pomalidomide is also available as a generic product with the FDA approving the first generic pomalidomide product in 2020.6 (see Table3,4)

Important Patient Counseling Information

Patients must read and agree to all the instructions in the appropriate REMS programs before initiating therapy. Lenalidomide and pomalidomide may cause serious adverse effects including the following:

  • Embryo-fetal toxicity—Patients must not use lenalidomide or pomalidomide during pregnancy. These medications may cause birth defects or embryo-fetal death. Females of reproductive potential must prevent pregnancy before, during, and after treatment by using 2 reliable contraception methods. Male and female patients must comply with all contraceptive requirements in the REMS programs.3,4
  • Venous and arterial thromboembolism—Lenalidomide and pomalidomide can cause deep vein thrombosis, pulmonary embolism, myocardial infarction, and stroke. Thromboprophylaxis is recommended. Providers should base the choice of regimen on an assessment of the patient’s underlying risk factors.3,4
  • Hematologic toxicity—Lenalidomide can cause significant neutropenia and thrombocytopenia. Providers must monitor patients with neutropenia for signs of infection. Patients must watch for bleeding and bruising especially when they use other medication that may increase bleeding risk.3

Yvonne Riley-Poku, PharmD, is a non-credit lecturer for the Pharmacy Technician Certification Program at Housatonic Community College, Bridgeport, Connecticut.


  1. Multiple Myeloma. Mayo Clinic. Updated June 16, 2021. Accessed July 14, 2021. https://www.mayoclinic.org/diseases-conditions/multiple-myeloma/symptoms-causes/syc-20353378
  2. About Multiple Myeloma. American Cancer Society. Accessed July 14, 2021. https://www.cancer.org/cancer/multiple-myeloma/about.html
  3. Revlimid. Prescribing information. Bristol Myers Squibb;2019. Accessed July 14, 2021. https://packageinserts.bms.com/pi/pi_revlimid.pdf
  4. Pomalyst. Prescribing information. Bristol Myers Squibb;2020. Accessed July 14, 2021. https://packageinserts.bms.com/pi/pi_pomalyst.pdf
  5. Revlimid FDA approval history. Drugs.com. Updated September 7, 2020. Accessed July 14, 2021. https://www.drugs.com/history/revlimid.html
  6. Pomalyst FDA approval history. Drugs.com. Updated March 16, 2021. Accessed July 14, 2021. https://www.drugs.com/history/pomalyst.html