The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone as second-line treatment for patients with multiple myeloma.
The approval is based on results from a phase 3 trial that evaluated carfilzomib in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in 792 patients with relapsed or refractory multiple myeloma after one to three lines of prior therapy. Patients were treated for a maximum of 18 cycles.
Results of that study (ASPIRE) showed a statistically significant improvement in progression-free survival with the three-drug combination compared with the two-drug combination.
In regard to safety, adverse events related to carfilzomib were similar to those described in the current prescribing information. Researchers found that cardiovascular events, venous thromboembolic events, and thrombocytopenia were more common in the carfilzomib group.
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The approval also includes a labeling change for Warnings and Precautions to alert health care professionals of the risk for venous thromboembolic events, cardiotoxicities, acute renal failure, pulmonary toxicities, and hypertension.
The FDA initially approved carfilzomib in 2012 for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
- Carfilzomib/Kyprolis. U.S. Food and Drug Administration: Approved Drugs. July 24, 2015. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm455873.htm. Accessed July 24, 2015.