FDA Statement Regarding IMids and Secondary Malignancies

On April 8, 2011, the FDA released a statement stating that the agency is “aware of results from clinical trials … that have found that patients treated with lenalidomide may be at an increased risk of developing new types of cancer compared to patients who did not take the drug.” For this reason, the FDA “is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.” While the FDA did not report or suggest that they have any evidence at this time that thalidomide may increase rates of secondary malignancies in MM patients, it has been included in the FDA investigation because “lenalidomide and thalidomide are chemically very similar to one another.”