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Celgene Corp., Summit, N.J., recently received Food & Drug Administration approval for lenalidomide (Revlimid) for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. MDS is a group of hematologic disorders in which the bone marrow does not function normally, producing immature cells that may result in anemia, neutropenia, and/or thrombocytopenia.
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"Revlimid is an analog of thalidomide that is more potent but less toxic," said Thomas Bechtel, Pharm.D., a specialty practice pharmacist in bone marrow transplantation at the James Cancer Hospital, Ohio State University Medical Center. Its exact mechanism isn't yet known, but the drug possesses antiangiogenic and immunomodulatory properties, including "inhibiting the production of proinflammatory cytokines such as IL-6 and TNF alpha, stimulating the production of anti-inflammatory cytokines such as IL-2 and gamma interferon, as well as enhancing the activity of natural killer cells."
Lenalidomide is classified as Pregnancy Category X. Since the drug is structurally similar to thalidomide, there is still concern that teratogenicity, although not yet seen, may occur when larger numbers of patients begin using it, Bechtel said. Until the results of ongoing animal studies are known, the company is marketing lenalidomide through a risk management plan called RevAssist, designed to prevent fetal exposure. The program allows access to the drug only to licensed prescribers who are registered in the program.
According to the manufacturer, 80% of patients in clinical trials required dose delay or reduction due to neutropenia and thrombocytopenia. Patients should have complete blood counts monitored weekly for the first eight weeks and at least monthly thereafter. Patients may also require use of blood product support and/or growth factors. The drug also significantly increases the risk of deep vein thrombosis and pulmonary embolism in patients with multiple myeloma who were treated with lenalidomide combination therapy. Patients should be warned to seek medical care if they develop shortness of breath, chest pain, or arm or leg swelling.
Additional information about RevAssist can be accessed on-line at http://www.revlimid.com/ or by calling 1-888-4CELGEN.