Lenalidomide May Up Risk of Developing New Cancers

But FDA determines benefits of the drug outweigh the potential risks

MONDAY, April 11 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care providers that lenalidomide (Revlimid) appears to be associated with an increased risk of developing new types of cancer.

Lenalidomide is indicated for the treatment of myelodysplastic syndrome and may be used in combination with dexamethasone to treat multiple myeloma. Clinical studies completed inside and outside the United States found that individuals undergoing treatment with lenalidomide were at an increased risk of developing new types of cancer, particularly acute myelogenous leukemia and B-cell lymphoma malignancies, compared with those not taking the drug.

Currently, the FDA believes the benefits of lenalidomide continue to outweigh the potential risks. The FDA recommends that patients continue the treatment as prescribed by their health care provider.

According to the FDA, "at this time, there is no recommendation to delay, modify or restrict the use of Revlimid for patients being treated according to the FDA-approved indications. FDA is currently reviewing all available information on this potential [risk] and will communicate any new recommendations once it has completed its review."

More Information

Physician's Briefing