Patients with newly diagnosed multiple myeloma who receive Revlimid® (lenalidomide) may be at an increased risk of developing new cancers, according to a safety announcement released by the U.S. Food and Drug Administration (FDA).
Revlimid is an oral medication that can stop or slow the growth of cancerous myeloma cells within the bone marrow. It has been approved in combination with dexamethasone for multiple myeloma patients who have received at least one prior therapy. Revlimid has also been evaluated in combination with other agents for the initial treatment of patients with newly diagnosed myeloma.
Clinical trials have been ongoing since Revlimid was approved and new data indicates that newly diagnosed patients treated with Revlimid have an increased risk of developing acute myelogenous leukemia (AML), myelodysplastic syndromes, and Hodgkin’s lymphoma.
One analysis included three randomized trials in which patients with newly diagnosed multiple myeloma received initial chemotherapy or chemotherapy and blood-stem-cell transplantation followed by treatment with Revlimid or placebo. The FDA reports that there was nearly a three-fold increase in new cancers in the Revlimid group compared to the placebo group, with 65 second primary cancers among 824 Revlimid patients and 19 second primary cancers among 665 placebo patients. The median time from start of Revlimid to a diagnosis of a second primary malignancy was two years.
The safety information has been added to Revlimid’s label to provide up-to-date information to healthcare professionals. The patient information is also being updated.
The FDA has recommended that doctors consider both the potential benefit of Revlimid as well as the risk of new cancers when choosing to treat patients with the drug. Patients must be closely monitored for the development of new cancers.
FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies [FDA Safety Announcement]. U.S. Food and Drug Administration website. Available at:
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