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The Food and Drug Administration has expanded the approved indication for lenalidomide plus dexamethasone to include patients newly diagnosed with multiple myeloma, Celgene announced on Feb. 18.
Lenalidomide – a thalidomide analogue with immunomodulatory, antiangiogenic, and antineoplastic properties – was approved as a treatment for multiple myeloma in patients who have received at least one previous therapy in 2006. Celgene markets lenalidomide as Revlimid.
Approval of the expanded indication was based on phase III trials, including the FIRST trial, an open-label, randomized study, comparing lenalidomide plus dexamethasone continuously for 18 months to melphalan, prednisone, and thalidomide (MPT) in 1,623 patients newly diagnosed with multiple myeloma who were not candidates for a stem cell transplant, according to the Celgene statement announcing the approval. A secondary analysis involved a subgroup of patients treated with a fixed duration of 18 cycles of lenalidomide and dexamethasone.
The median progression-free survival (PFS), the primary endpoint, was 25.5 months among those on continuous lenalidomide and dexamethasone therapy, vs. 21.2 months among those treated with MPT, a statistically significant difference (hazard ratio, 0.72). An interim analysis of overall survival in March 2014 determined that the median overall survival was 58.9 months among those in the continuous lenalidomide-dexamethasone group, vs. 48.5 months among those in the MPT group (HR, 0.75).
Almost half of those on continuous treatment had diarrhea, vs. 16.5% of those on MPT. Other adverse events reported in 20% or more of patients included anemia in 44% and 42% and neutropenia in 35% and almost 61%, in these two groups respectively.
Lenalidomide is currently under review in Europe for treating adults with previously untreated multiple myeloma, who are not eligible for transplant, according to the company.
Lenalidomide is approved with a Risk Evaluation and Mitigation Strategy (REMS) to prevent embryo-fetal exposure and to inform patients, prescribers, and pharmacists about the serious risks associated with treatment.
The updated prescribing information is available at www.revlimid.com/wp-content/uploads/2013/11/PI.pdf.
The Food and Drug Administration has expanded the approved indication for lenalidomide plus dexamethasone to include patients newly diagnosed with multiple myeloma, Celgene announced on Feb. 18.
Lenalidomide – a thalidomide analogue with immunomodulatory, antiangiogenic, and antineoplastic properties – was approved as a treatment for multiple myeloma in patients who have received at least one previous therapy in 2006. Celgene markets lenalidomide as Revlimid.
Approval of the expanded indication was based on phase III trials, including the FIRST trial, an open-label, randomized study, comparing lenalidomide plus dexamethasone continuously for 18 months to melphalan, prednisone, and thalidomide (MPT) in 1,623 patients newly diagnosed with multiple myeloma who were not candidates for a stem cell transplant, according to the Celgene statement announcing the approval. A secondary analysis involved a subgroup of patients treated with a fixed duration of 18 cycles of lenalidomide and dexamethasone.
The median progression-free survival (PFS), the primary endpoint, was 25.5 months among those on continuous lenalidomide and dexamethasone therapy, vs. 21.2 months among those treated with MPT, a statistically significant difference (hazard ratio, 0.72). An interim analysis of overall survival in March 2014 determined that the median overall survival was 58.9 months among those in the continuous lenalidomide-dexamethasone group, vs. 48.5 months among those in the MPT group (HR, 0.75).
Almost half of those on continuous treatment had diarrhea, vs. 16.5% of those on MPT. Other adverse events reported in 20% or more of patients included anemia in 44% and 42% and neutropenia in 35% and almost 61%, in these two groups respectively.
Lenalidomide is currently under review in Europe for treating adults with previously untreated multiple myeloma, who are not eligible for transplant, according to the company.
Lenalidomide is approved with a Risk Evaluation and Mitigation Strategy (REMS) to prevent embryo-fetal exposure and to inform patients, prescribers, and pharmacists about the serious risks associated with treatment.
The updated prescribing information is available at www.revlimid.com/wp-content/uploads/2013/11/PI.pdf.
The Food and Drug Administration has expanded the approved indication for lenalidomide plus dexamethasone to include patients newly diagnosed with multiple myeloma, Celgene announced on Feb. 18.
Lenalidomide – a thalidomide analogue with immunomodulatory, antiangiogenic, and antineoplastic properties – was approved as a treatment for multiple myeloma in patients who have received at least one previous therapy in 2006. Celgene markets lenalidomide as Revlimid.
Approval of the expanded indication was based on phase III trials, including the FIRST trial, an open-label, randomized study, comparing lenalidomide plus dexamethasone continuously for 18 months to melphalan, prednisone, and thalidomide (MPT) in 1,623 patients newly diagnosed with multiple myeloma who were not candidates for a stem cell transplant, according to the Celgene statement announcing the approval. A secondary analysis involved a subgroup of patients treated with a fixed duration of 18 cycles of lenalidomide and dexamethasone.
The median progression-free survival (PFS), the primary endpoint, was 25.5 months among those on continuous lenalidomide and dexamethasone therapy, vs. 21.2 months among those treated with MPT, a statistically significant difference (hazard ratio, 0.72). An interim analysis of overall survival in March 2014 determined that the median overall survival was 58.9 months among those in the continuous lenalidomide-dexamethasone group, vs. 48.5 months among those in the MPT group (HR, 0.75).
Almost half of those on continuous treatment had diarrhea, vs. 16.5% of those on MPT. Other adverse events reported in 20% or more of patients included anemia in 44% and 42% and neutropenia in 35% and almost 61%, in these two groups respectively.
Lenalidomide is currently under review in Europe for treating adults with previously untreated multiple myeloma, who are not eligible for transplant, according to the company.
Lenalidomide is approved with a Risk Evaluation and Mitigation Strategy (REMS) to prevent embryo-fetal exposure and to inform patients, prescribers, and pharmacists about the serious risks associated with treatment.
The updated prescribing information is available at www.revlimid.com/wp-content/uploads/2013/11/PI.pdf.