Celgene Says FDA Expanded Existing Indication For REVLIMID - Quick Facts

(RTTNews) - Celgene Corp. (CELG) announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for REVLIMID (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (NDMM).

REVLIMID plus dexamethasone was previously approved in June 2006 for use in multiple myeloma patients who have received at least one prior therapy.

The approval was based on safety and efficacy results from phase III studies, including the FIRST trial (MM-020/IFM 07-01), which evaluated continuous REVLIMID in combination with dexamethasone (Rd Continuous) until disease progression versus melphalan, prednisone and thalidomide (MPT) for 18 months as the primary analysis, and a fixed duration of 18 cycles of Rd (Rd18) as a secondary analysis, in 1,623 newly diagnosed patients who were not candidates for stem cell transplant.