Revlimid lenalidomide: Phase III data

The open-label, international Phase III FIRST (MM-020/IFM 07-01) trial in 1,623 patients with newly diagnosed MM who were ineligible for autologous stem cell transplantation (ASCT) showed that continuous oral Revlimid plus low-dose dexamethasone until disease progression met the primary endpoint of improving median PFS vs. a combination of melphalan, prednisone and thalidomide. Patients received continuous oral Revlimid plus low-dose dexamethasone until disease progression, Revlimid plus low-dose dexamethasone for 72 weeks or melphalan, prednisone and thalidomide for up to 72 weeks. Celgene said it plans to submit regulatory applications in the U.S., EU and other countries for Revlimid in newly diagnosed MM starting in 4Q13. ...