FDA expands indication for Revlimid in combination with dexamethasone

The FDA has expanded the existing indication for Celgene's Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Revlimid plus dexamethasone was previously approved in 2006 for use in multiple myeloma patients who have received at least one prior therapy. The new approval was based on safety and efficacy results from phase III studies, including the FIRST trial, 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(ClinicalTrials.gov Identifier NCT00689936).

In this randomized, open-label, three-arm trial, median progression-free survival (PFS) was significantly longer for patients receiving Rd Continuous (25.5 months) than for those treated with MPT (21.2 months). Median overall survival in the two groups was 58.9 months and 48.5 months, respectively. Patients in the Rd Continuous arm had a 25% reduction in the risk of death compared with patients in the MPT arm. Celgene currently has an application under review with the EMA for approval to use Revlimid for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. The EMA's Committee for Medicinal Products for Human Use published a positive opinion for this application last year (Celgene News Release).