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FDA Approves New Use for Cancer Drug Lenalidomide (Revlimid)

Treatment now indicated for newly diagnosed multiple myeloma patients

The FDA has expanded the existing indication for lenalidomide (Revlimid, Celgene Corporation) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in 2006 for use in multiple myeloma patients who had received at least one prior therapy.

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

Median progression-free survival, the trial’s primary endpoint, was significantly longer for patients receiving continuous Rd than for those treated with MPT (25.5 months vs. 21.2 months, respectively; hazard ratio [HR], 0.72; P = 0.0001). Median overall survival in the two groups was 58.9 months and 48.5 months, respectively (HR, 0.75). Patients in the continuous Rd arm showed a 25% reduction in the risk of death compared with those in the MPT arm.

Adverse events reported in the continuous Rd, Rd18, and MPT arms included diarrhea (46%, 38.5%, 17%, respectively); anemia (44%, 36%, 42%); neutropenia (35%, 33%, 61%); fatigue (33%, 33%, 29%); back pain (32%, 27%, 21%); insomnia (28%, 24%, 10%); asthenia (28%, 23%, 23%); rash (26%, 28%, 19%); decreased appetite (23%, 21%, 13%); cough (23%, 17%, 13%); pyrexia (21%, 19%, 14%); muscle spasms (21%, 19%, 11%); and abdominal pain (21%, 14%, 11%).

The most frequently reported grade-3 or grade-4 events in the continuous Rd arm (until disease progression) included neutropenia (28%), anemia (18%), thrombocytopenia (8%), pneumonia (11%), asthenia (8%), fatigue (7%), back pain (7%), hypokalemia (7%), rash (7%), cataract (6%), dyspnea (6%), deep vein thrombosis (6%), and hyperglycemia (5%).

Source: Celgene; February 18, 2015.

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