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Lenalidomide investigation of risk of second primary malignancies in myeloma

31st May 2011

Data from three large controlled clinical trials investigating use of lenalidomide in patients with newly diagnosed multiple myeloma have recently shown a signal of an apparent excess of second primary malignancies. On the basis of this observation, a review of the balance of benefits and risks of lenalidomide in its authorised indication is being undertaken in the EU. The UK MHRA have stated that the use of lenalidomide in newly diagnosed multiple myeloma or other unlicensed indications is not recommended and that healthcare professionals should be vigilant for the occurrence of second primary malignancies, and should report such events promptly. For further information see the May 2011 edition of the MHRA Drug Safety Update.

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