ASCOPost.com | MAY 1, 2011
PAGE 33
FDA Update
FDA Investigating Risk of New Malignancies with Lenalidomide
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n a recent Drug Safety Communication, the FDA informed the public that it is aware of results from clinical trials showing that patients treated with lenalidomide (Revlimid) may be at an increased risk of developing new
types of cancer compared to patients who did not take the drug. The Agency is reviewing all available information on this potential risk and will communicate any new recommen-
dations once it has completed its review. Lenalidomide (Revlimid) is approved for use, in combination with dexamethasone, for the treatment of patients with mul-
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tiple myeloma who have received at least one prior therapy. The drug is also approved for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1–risk myelodyscontinued on page 34