FDA Alerts
FDA Approves Lenalidomide
On June 5, 2013, the US Food and Drug Administration approved lenalidomide capsules (REVLIMID, Celgene Corporation), for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Revlimid and Risk of New Cancers
The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid ( lenalidomide ).
FDA Drug Safety Communication: Revlimid
The U.S. Food and Drug Administration (FDA) is informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with Revlimid ( lenalidomide ) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug.
FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.
At this time, FDA recommends that patients continue their Revlimid treatment as prescribed by their...