Database study of lenalidomide (Revlimid ® ) in Germany: monitoring off-label use

Michael Dörks, Ingo Langner, Sigrid Behr, Antje Timmer & Edeltraut Garbe
Background: Lenalidomide, a derivate of thalidomide, in combination with dexamethasone is indicated for the treatment of multiple myeloma in patients who have received at least one prior therapy. In the USA, lenalidomide is also licensed for the treatment of a certain form of myelodysplastic syndromes (MDS). Monitoring of off-label use in Germany is part of the risk management plan mandated by the regulatory authority. Material and methods: Our retrospective epidemiological study was based on claims...