FDA expands indication for Revlimid in Multiple Myeloma-Celgene

The FDA has expanded the existing indication for Revlimid (lenalidomide), from Celgene Corp, 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.

PFS was significantly longer for patients receiving Rd Continuous (25.5 months) than for those treated with MPT (21.2 months). Median overall survival (OS) in the two groups was 58.9 months and 48.5 months, respectively based on a March 3, 2014 interim OS analysis. Patients in the Rd Continuous arm had a 25% reduction in the risk of death compared to patients in the MPT arm. Safety results showed that adverse reactions reported in ?20% of NDMM patients in the Rd Continuous, Rd18 or MPT arms included diarrhea (45.5%, 38.5%, 16.5%), anemia (43.8%, 35.7%, 42.3%) and neutropenia (35.0%, 33.0%, 60.6%)

Comment: The drug is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand. Celgene currently has an application under review with the European Medicines Agency (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 in December 2014.