BETHESDA, MD 08 May 2012—FDA on May 7 announced safety-related changes to the labeling for lenalidomide.

According to FDA, data from clinical trials conducted after the drug was approved indicate that patients newly diagnosed with multiple myeloma who receive maintenance treatment with lenalidomide are at increased risk for the development of new primary malignancies.

The study participants had undergone chemotherapy alone or with stem cell transplantation before starting maintenance treatment with lenalidomide or receiving a placebo.

According to FDA, 7.9% of patients treated with lenalidomide and 2.8% of placebo recipients were later diagnosed with a myelogenous leukemia, myelodysplastic syndromes, Hodgkin disease, or another new malignancy. In half of the patients, the new cancer occurred within two years of starting maintenance therapy.

No increase was observed in the risk for nonmelanoma skin cancers or solid tumors in patients treated with lenalidomide.

The labeling and medication guide for lenalidomide are being revised to include the new safety information, according to FDA.

The agency asked health care providers to weigh the risks and benefits of lenalidomide when making treatment decisions and to monitor patients for secondary malignancies when using the drug.