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FDA expands approval of Revlimid for newly diagnosed multiple myeloma
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The FDA today expanded the existing indication of lenalidomide plus dexamethasone to include patients with newly diagnosed multiple myeloma, according to a press release from the drug’s manufacturer.
In June 2006, lenalidomide (Revlimid, Celgene) in combination with dexamethasone received FDA approval for the treatment of patients with multiple myeloma who had received at least one prior therapy.
“The approval of Revlimid as an option for use in all patients with multiple myeloma represents a new paradigm in the management of this disease,” Kenneth Anderson, MD, director of the Jerome Lipper Multiple Myeloma Center, Dana-Farber/Brigham and Women’s Cancer Center, said in a press release. “We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival.”
The FDA based its decision to expand the approval of lenalidomide on results from phase 3 studies, including the FIRST trial (MM-020/IFM 07-01), which evaluated continuous lenalidomide combined with dexamethasone (Rd Continuous) until disease progression vs. melphalan, prednisone and thalidomide (MPT) for 18 months as the primary analysis.
As a secondary analysis, researchers evaluated a fixed duration of 18 cycles of lenalidomide combined with dexamethasone in 1,623 newly diagnosed patients who were not eligible for stem cell transplant.
Median PFS was the primary endpoint of this randomized, open-label, three-arm trial.
PFS was significantly longer for patients who received Rd Continuous (25.5 months) vs. patients treated with MPT (21.2 months; HR = 0.72; P = .0001).
Median OS in the two groups was 58.9 months in the Rd Continuous group vs. 48.5 months in the MPT group (HR = 0.75; 95% CI, 0.62-0.9), based on a March 3, 2014, interim OS analysis. Patients in the Rd Continuous group had a 25% reduction in the risk of death compared with patients in the MPT arm.
The most common adverse events reported in both groups included diarrhea, anemia, neutropenia, fatigue and back pain.
Perspective
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Sagar Lonial, MD
The approval by the FDA for the use of lenalidomide plus dexamethasone as induction therapy for myeloma is an important step forward for patients, not only from an access perspective, but more importantly from the perspective of the data used to support the approval. The FIRST trial was a landmark study, as it definitively proved that a non–melphalan-based induction could improve OS among patients who are not proceeding to transplant. Although operationally in the United States we have presumed this result, there were no solid data proving this point. What this means for patients is that, as we have more and more tools to combine, we can think toward a chemotherapy-free approach for the management of patients with myeloma. Immunomodulatory drugs (IMID)/proteasome inhibitors and IMID/monoclonal antibody combinations are just the tip of the iceberg as we begin to develop more effective treatments for patients with myeloma. Many have argued that the best time to make the greatest impact on remission is at the time of diagnosis. With this approval, and the data that supports it, we now have the evidence to begin to realize that opportunity.
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