The FDA is informing the public that it is conducting an ongoing safety review of clinical trial data suggesting that patients treated with Revlimid (lenalidomide; Celgene) may be at an increased risk of developing new types of cancer compared with patients who did not take the drug. Preliminary data derived from evaluation of longer-term exposure to Revlimid and from controlled clinical trials conducted inside and outside the U.S. shows an increased incidence of some second primary malignancies, particularly acute myelogenous leukemia (AML) and B-cell lymphoma malignancies, when compared with controls.

At this time, FDA recommends that patients continue their Revlimid treatment as prescribed by their healthcare provider. There is no recommendation to delay, modify or restrict the use of Revlimid for patients being treated according to the FDA-approved indications.

Revlimid is approved for use, in combination with dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Revlimid is also approved for treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.

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