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The Food and Drug Administration has approved carfilzomib (Kyprolis) to be used in combination with lenalidomide (Revlimid) and dexamethasone for patients with relapsed multiple myeloma who have received one to three prior lines of therapy.
The expanded indication for carfilzomib was based on the results of the ASPIRE trial of 792 patients with relapsed or refractory multiple myeloma who were randomized to receive lenalidomide and dexamethasone with or without carfilzomib for 18 cycles. Progression-free survival was significantly longer among patients receiving the three-drug regimen that included carfilzomib (26.3 months), compared with those in the two-drug arm (17.6 months).
The safety profile of carfilzomib used in combination was similar to that described on the current label. Side effects that occurred more frequently with the three-drug regimen included cardiovascular events, venous thromboembolic events, and thrombocytopenia.
Along with the approval, the labeling has been revised to include new warnings and precautions for venous thromboembolic events, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. Also, there are increased safety risks indicated for elderly patients.
The recommended dose-schedule for carfilzomib has also been revised for use as monotherapy or in combination with lenalidomide and dexamethasone.
Carfilzomib is manufactured by Onyx Pharmaceuticals under the trade name Kyprolis.
The Food and Drug Administration has approved carfilzomib (Kyprolis) to be used in combination with lenalidomide (Revlimid) and dexamethasone for patients with relapsed multiple myeloma who have received one to three prior lines of therapy.
The expanded indication for carfilzomib was based on the results of the ASPIRE trial of 792 patients with relapsed or refractory multiple myeloma who were randomized to receive lenalidomide and dexamethasone with or without carfilzomib for 18 cycles. Progression-free survival was significantly longer among patients receiving the three-drug regimen that included carfilzomib (26.3 months), compared with those in the two-drug arm (17.6 months).
The safety profile of carfilzomib used in combination was similar to that described on the current label. Side effects that occurred more frequently with the three-drug regimen included cardiovascular events, venous thromboembolic events, and thrombocytopenia.
Along with the approval, the labeling has been revised to include new warnings and precautions for venous thromboembolic events, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. Also, there are increased safety risks indicated for elderly patients.
The recommended dose-schedule for carfilzomib has also been revised for use as monotherapy or in combination with lenalidomide and dexamethasone.
Carfilzomib is manufactured by Onyx Pharmaceuticals under the trade name Kyprolis.
The Food and Drug Administration has approved carfilzomib (Kyprolis) to be used in combination with lenalidomide (Revlimid) and dexamethasone for patients with relapsed multiple myeloma who have received one to three prior lines of therapy.
The expanded indication for carfilzomib was based on the results of the ASPIRE trial of 792 patients with relapsed or refractory multiple myeloma who were randomized to receive lenalidomide and dexamethasone with or without carfilzomib for 18 cycles. Progression-free survival was significantly longer among patients receiving the three-drug regimen that included carfilzomib (26.3 months), compared with those in the two-drug arm (17.6 months).
The safety profile of carfilzomib used in combination was similar to that described on the current label. Side effects that occurred more frequently with the three-drug regimen included cardiovascular events, venous thromboembolic events, and thrombocytopenia.
Along with the approval, the labeling has been revised to include new warnings and precautions for venous thromboembolic events, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. Also, there are increased safety risks indicated for elderly patients.
The recommended dose-schedule for carfilzomib has also been revised for use as monotherapy or in combination with lenalidomide and dexamethasone.
Carfilzomib is manufactured by Onyx Pharmaceuticals under the trade name Kyprolis.
