Revlimid Gets Expanded Multiple Myeloma Indication

Celgene announced that the Food and Drug Administration (FDA) has expanded the use of Revlimid (lenalidomide) to include patients newly diagnosed with multiple myeloma, in combination with dexamethasone.

Revlimid is an immunomodulator already approved for use in combination with dexamethasone for treatment of patients with multiple myeloma who have received at least one prior therapy, and for treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

The expanded approval was based on data from Phase 3 studies, including the FIRST trial that studied continuous Revlimid in combination with dexamethasone until disease progression vs. melphalan, prednisone, and thalidomide (MPT) for 18 months, in newly diagnosed patients who were not stem cell transplant candidates. Patients treated with Revlimid plus dexamethasone had a significantly longer progression-free survival (PFS) than those treated with MPT (25.5 months vs. 21.2 months; HR 0.72; P=0.0001). Median overall survival was also higher in the Revlimid plus dexamethasone group vs. the MPT group (58.9 months vs.48.5 months; HR 0.75). Further, a 25% reduction in risk of death was seen in the Revlimid plus dexamethasone group vs. the MPT group.

Revlimid is available as 2.5mg, 5mg, and 10mg strength capsules in 28- and 100-count bottles, and as 15mg, 20mg, and 25mg strength capsules in 21- and 100-count bottles.

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