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Revlimid Label Updated With Cancer Warnings, FDA Says

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Drug maker, Celgene’s, Revlimid’s (lenalidomide) label has been updated with cancer warnings, the U.S. Food & Drug Administration (FDA) just announced. Revlimid is used with other drugs for the treatment of multiple myeloma (cancer of plasma cells) and is also prescribed to treat a blood disorder called

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myelodysplastic syndrome.

The FDA just issued a broad update concerning the risk of developing a second cancer when being treated with Revlimid, as well as specific information concerning its analysis of the drug and second cancers, said the Myeloma Beacon.

In its update, the FDA indicated that physicians should continue to monitor patients treated with Revlimid for the development of second cancers and consider risks and benefits to patients when considering prescribing Revlimid, said the Myeloma Beacon.

The agency’s analyses revealed that patients recently diagnosed with multiple myeloma who were treated with Revlimid maintenance therapy following stem cell transplantation are three times likelier to develop a second cancer versus patients not on Revlimid maintenance, explained Myeloma Beacon. The analysis reviewed data from three, current clinical trials that indicated that 7.9% of newly diagnosed multiple myeloma Revlimid patients developed a second cancer, versus 2.8% in the placebo group; Revlimid patients were likelier to be diagnosed with acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin’s lymphoma, said the FDA. The median time frame from initiating Revlimid treatment until second cancer diagnosis was two years, Myeloma Beacon explained.

The revised safety information was added to the Warnings and Precautions section of Revlimid’s drug label, said the FDA, adding that the patient Medication Guide is also being updated to inform patients about this risk.

Just last week, Health Canada issued a cancer warning over Revlimid regarding secondary cancers.

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