The November 2011 issue of Drug Safety Update from the MHRA features an update about the risk of a second primary malignancy associated with the use of lenalidomide. The Drug Safety Update notes that in clinical trials of newly diagnosed multiple myeloma (unauthorised indication), a four-fold increased incidence of second primary malignancy has been observed in patients receiving lenalidomide (7.0 %) compared with controls (1.8%). The median follow-up for participants with newly diagnosed myeloma in clinical trials ranged from 27.2 months to 36.5 months. However, there seems to be a smaller increased risk of second primary malignancy in patients treated with lenalidomide for relapsed or refractory myeloma—the authorised indication.

The MHRA has therefore issued the following advice for healthcare professionals (taken directly from source):

• Use of lenalidomide in unlicensed indications is not recommended unless it takes place as part of a clinical trial

• Patients should be carefully evaluated before and during treatment with lenalidomide using routine cancer screening for occurrence of second primary malignancy and treatment should be instituted as indicated

• Healthcare professionals should report all suspected adverse reactions, including second primary malignancy promptly to us via the Yellow Card Scheme