The ASCO Post  |   MAY 1, 2011
PAGE 34
FDA Update
Lenalidomide Malignancies continued from page 33
plastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
Benefits Outweigh Risks FDA believes the benefits of
lenalidomide continue to outweigh the potential risks. At this time, there is no recommendation to delay, modify, or restrict the use of lenalidomide for patients being treated according to the FDA-approved indications. The announcement adds that health-care professionals should carefully weigh
the benefits and risks of the drug when prescribing it. Preliminary data derived from evaluation of outcomes after longer-term exposure to lenalidomide and from controlled clinical trials shows an increased incidence of some second primary malignancies, particularly acute
myelogenous leukemia and B-cell lymphoma malignancies, compared to controls. Since lenalidomide is an analog of thalidomide (Thalomid), FDA is also currently reviewing all available information on this potential risk for thalidomide.
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