Revlimid lenalidomide regulatory update

Celgene withdrew a European application to extend the label of multiple myeloma (MM) drug Revlimid lenalidomide to include maintenance treatment in newly diagnosed MM patients who have not progressed following initial treatment, or as maintenance therapy following autologous stem cell transplantation. According to Celgene, EMA's CHMP said it needs more mature data before it can make a benefit-risk decision on the application. Celgene said the committee expressed concerns about the potential effect of second primary malignancies on survival. Celgene plans to evaluate long-term follow-up data every 3 months from the 3 ongoing Revlimid trials included in the submission. The company said it will reexamine within the next 3-6 months the opportunity for resubmission. ...