Celgene has announced that both the European Commission (EC) and the US Food and Drug Administration (FDA) have approved the use of lenalidomide (Revlimid®) as maintenance treatment for myeloma patients following high-dose therapy and autologous stem cell transplantation (ASCT). Based on data from the CALGB 100104 and IFM 2005-02, the expanded indication for lenalidomide means that it is the first treatment in myeloma to receive approval  as a maintenance treatment post-ASCT. Both trials showed progression-free survival for patients who had lenalidomide maintenance compared to those who did not, although the benefits on overall survival were inconclusive. The frequency of second primary malignancies was also greater in the maintenance treatment group (7.5%) compared to those in the non-maintenance group (3.3%). However, the potential benefits of lenalidomide maintenance treatment were deemed to outweigh the risks. The recommended dose and schedule is 10mg orally once daily continuously on days 1 to 28 of each 28-day cycle.

 

Read EC approval article

Read FDA approval article