The U.S. Food and Drug Administration (FDA) has approved carfilzomib in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received 1 to 3 lines of therapy.1
The FDA also converted carfilzomib’s initial single-agent accelerated approval in the same treatment setting to a full approval.
“Kyprolis is the only approved therapy for relapsed multiple myeloma with proven efficacy as a single agent, doublet and triplet combination that is offered in a variety of doses to meet individual patient needs,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen.
“Importantly, this new approval supports the use of Kyprolis as a backbone therapy for the management of relapsed multiple myeloma, a difficult-to-treat blood cancer.”
Approval is based on findings from the phase 3 ENDEAVOR trial, which showed that patients with relapsed multiple myeloma who were treated with carfilzomib had a median progression-free survival of 18.7 months compared with 9.4 months in those treated with bortezomib (HR=0.53; 95% CI: 0.44-0.65).
A total of 929 patients were randomly assigned to receive either carfilzomib 20 mg/m2 on days 1 and 2, followed by 56 mg/m2 on days 8, 9, 15, and 16 for the 28-day cycle 1 only plus dexamethasone 20 mg on days 1, 2, 8, 9, 15, 16, 22, and 23; or bortezomib 1.3 mg/m2 SC or IV on days 1, 4, 8, and 11 plus dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
The most frequently reported adverse events in the carfilzomib arms were anemia, diarrhea, dyspnea, fatigue, insomnia, pyrexia, and thrombocytopenia.
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“Multiple myeloma remains an incurable disease where relapse inevitably occurs and over time patients become resistant to treatments,” said Ruben Niesvizky, MD, director of the Multiple Myeloma Center at Weill Cornell Medicine and New York-Presbyterian/Weill Cornell Medical Center in New York City. “As a clinician, I’m pleased with the tremendous progress that we have seen in the past 12 months in multiple myeloma treatment.”
“This FDA approval is important because it provides physicians with flexible options for Kyprolis use in helping to manage this challenging disease,” Dr Niesvizky said.
- FDA approves new Kyprolis® (carfilzomib) combination therapy for the treatment of patients with relapsed or refractory multiple myeloma [news release]. Thousand Oaks, CA: Amgen; January 21, 2016. http://www.amgen.com/media/news-releases/2016/01/fda-approves-new-kyprolis-carfilzomib-combination-therapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma. Accessed January 22, 2016.